WO2009154131A1 - Needle assembly - Google Patents

Needle assembly Download PDF

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Publication number
WO2009154131A1
WO2009154131A1 PCT/JP2009/060684 JP2009060684W WO2009154131A1 WO 2009154131 A1 WO2009154131 A1 WO 2009154131A1 JP 2009060684 W JP2009060684 W JP 2009060684W WO 2009154131 A1 WO2009154131 A1 WO 2009154131A1
Authority
WO
WIPO (PCT)
Prior art keywords
protective cover
hub
needle assembly
protrusion
cannula
Prior art date
Application number
PCT/JP2009/060684
Other languages
French (fr)
Japanese (ja)
Inventor
佳邦 内田
洋太 関塚
寛和 須藤
Original Assignee
ニプロ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ニプロ株式会社 filed Critical ニプロ株式会社
Priority to US12/737,093 priority Critical patent/US9061105B2/en
Priority to CA2728148A priority patent/CA2728148C/en
Priority to EP09766579.8A priority patent/EP2298394A4/en
Priority to JP2010517879A priority patent/JP5267560B2/en
Publication of WO2009154131A1 publication Critical patent/WO2009154131A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • A61M5/3272Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps

Definitions

  • the present invention relates to a needle assembly, and more particularly to a needle assembly provided with a protective cover that moves to a forward position that surrounds the tip of the cannula and a retracted position that exposes the tip of the cannula.
  • a needle assembly includes an urging unit that is elastically disposed therebetween and urges a protective cover forward, and a stopper unit that holds the protective cover in the advanced position. Further, in such a needle assembly, the protective cover is in the forward position and the tip of the cannula is surrounded, and the protective cover is in the retracted position and the tip of the cannula is exposed.
  • Patent Document 1 There is also known a needle assembly that moves between a use state to be moved and a post-use state in which the tip of the cannula is surrounded again and fixed so as not to move to the retreat position again (Patent Document). 1, 2).
  • the insulin injection system of Patent Document 1 includes the hub, a protective cover provided so as to cover the outer peripheral surface of the hub, and a spring member provided inside the hub and in contact with the bottom portion on the front end side of the protective cover. It is configured.
  • an engagement protrusion is provided on the inner peripheral surface of the protective cover, and a guide groove for guiding the engagement protrusion is provided on the outer peripheral surface of the hub.
  • the guide groove moves forward while rotating along the groove formed obliquely forward when the cannula is located in the use state when the protective cover in the pre-use state is pressed backward to guide the engagement protrusion backward. And it comes to be located in the state after use.
  • the protrusion is fitted in a recess formed in the guide groove, so that the protective cover does not move backward again.
  • protrusions are provided on the inner peripheral surface of the cylindrical portion, the outer peripheral surface of the protective cover, and the outer peripheral surface of the fixing member, and these protrusions are appropriately inclined. .
  • the protective cover rotates while sliding between the inclined surfaces of the protrusions to become in use, and then the inclined surfaces of the protrusions move when the protective cover moves forward. Further, the protective cover rotates while sliding and is positioned in the post-use state. In this state after use, the protrusion and the protrusion come into contact with each other to prevent the protective cover from retreating.
  • the present invention provides a needle assembly that can be manufactured at low cost and can be used safely.
  • the needle assembly according to the invention of claim 1 is located at a hub that holds the cannula, a forward position that moves forward and backward with respect to the hub and surrounds the tip of the cannula, and a retracted position that exposes the tip of the cannula.
  • a needle cover provided with a protective cover, a biasing means that is elastically mounted between the hub and the protective cover and biases the protective cover forward, and a stopper means that holds the protective cover in the forward position.
  • a cylindrical portion surrounding the outer periphery of the protective cover is provided on the hub, And the spring part as said urging
  • the needle assembly according to the invention of claim 2 is located at a hub that holds the cannula, a forward position that moves forward and backward with respect to the hub and surrounds the tip of the cannula, and a retracted position that exposes the tip of the cannula.
  • a protective cover a biasing means that is elastically mounted between the hub and the protective cover and biases the protective cover forward, and a stopper means that holds the protective cover in the forward position
  • the pre-use state in which the protective cover is located at the forward position and the tip of the cannula is surrounded; the use state in which the protective cover is located at the retracted position and the tip of the cannula is exposed; and the forward position again
  • the hub is provided with a cylindrical portion that surrounds the outer periphery of the protective cover, and the engaging projection is moved to one of the hub body or the protective cover composed of the hub and the cylindrical portion, and the engaging projection is moved to the other.
  • Each is provided with a guide means to regulate,
  • the guide means engages when the pre-use holding portion that holds the engaging protrusion at the pre-use position, the post-use holding portion that fixes the engaging protrusion at the post-use state, and the protective cover is retracted.
  • An inclined surface that engages with the protrusion and retracts the protective cover while rotating from the pre-use holding unit side position toward the post-use holding unit side position,
  • the protective cover is retracted against the urging force of the urging means from the pre-use state, the engaging projection and the inclined surface come into contact with each other, and the protective cover moves backward while rotating to enter the use state.
  • the protective cover is moved forward from the state, the engaging protrusion is fixed to the post-use holding portion to be in the post-use state.
  • the cylindrical portion is provided so as to surround the protective cover, the user can perform injection while holding the protective cover.
  • the protective cover and the spring portion are integrally formed of a material having elasticity, the number of parts can be reduced as compared with Patent Documents 1 and 2, and the protective cover and the spring portion Are aligned in series, they can be easily formed integrally, and the needle assembly can be miniaturized.
  • the protective cover and the spring portion are formed separately, the spring receiving portion must be formed on the protective cover, which increases the size of the protective cover and the size of the entire needle assembly. there were.
  • the cylindrical portion is provided so as to surround the protective cover, the user can hold the protective cover and perform injection. Further, when the protective cover is moved from the pre-use position to the use position, the protective cover is rotated and retracted. Therefore, when the protective cover is subsequently moved from the use position to the post-use position, It moves forward by the urging force. That is, the engagement protrusion is configured to be difficult to rotate and move toward the holding unit before use, and malfunction can be prevented. Furthermore, the number of parts can be reduced as compared with the injection needle structure of Patent Document 2, and a needle assembly can be manufactured at low cost.
  • Sectional drawing which shows the state before use of the needle assembly concerning a 1st Example. Sectional drawing which shows the state after use of the said needle assembly.
  • the block diagram which shows the component of a needle assembly. It is a figure which shows operation
  • 2A and 2B are views showing a main body, in which FIG. 1A is a side view seen from the direction VV in FIG. 1, FIG. 2B is a front view with respect to FIG. 1A, and FIG. Sectional drawing cut
  • FIG. 1A is a cross-sectional view seen from the same direction as FIG. 1
  • FIG. 1B is a side view seen from the direction VV in FIG. (D) is a cross-sectional view taken along a line dd in (b).
  • the block diagram which shows the component of the needle
  • FIG. 1 to 3 show a needle assembly 1 used for insulin injection according to the first embodiment
  • FIG. 1 shows a needle assembly 1 in a pre-use state
  • FIG. 2 shows a post-use needle assembly 1.
  • 3 shows an exploded view of the needle assembly 1
  • FIG. 3 shows an exploded view of the needle assembly 1.
  • the needle assembly 1 is attached to the tip of a cartridge containing insulin (not shown).
  • the front or tip is the patient side on the right in FIG. 1 and FIG.
  • Each of the cartridge sides is indicated.
  • the needle assembly 1 includes a hub 4 that holds the cannula 3, a protection unit 5 that moves forward and backward with respect to the hub 4 and surrounds the tip of the cannula 3, and is connected to the front of the hub 4.
  • the protection unit 5 includes a protection cover 7 that protrudes and protrudes from the cylindrical portion 6, and a spring portion 8 provided in series at the rear end of the protection cover 7, and includes the hub 4, the cylindrical portion 6, and the like.
  • the needle assembly 1 of the present embodiment is in a pre-use state (FIG. 4A) in which the front end of the protection unit 5 is positioned at the advanced position, and the front end of the protection unit 5 is retracted. It is possible to change between a use state in which the cannula 3 can puncture the patient by moving to the position (FIG.
  • FIG. 5 (a) to 5 (c) show the hub 4
  • FIG. 5 (a) is a side view of the hub 4 seen from the direction VV in FIG. 1
  • FIG. 5C is a cross-sectional view taken along the line cc of FIG. 5B.
  • the hub 4 includes a cylindrical base portion 11 connected to the cartridge, a bottom portion 12 provided substantially at the center in the front-rear direction of the base portion 11, and a holder that protrudes forward from the center of the bottom portion 12 and holds the canula 3.
  • a portion 13 and two guide portions 14 projecting forward from the base portion 11 are configured.
  • a screw part that is screwed into the cartridge is formed on the inner peripheral surface of the base part 11 behind the bottom part 12, and the rear end of the spring part 8 of the protection unit 5 is in contact with the front part of the bottom part 12. (See FIG. 1).
  • the base 11 is provided on the outer peripheral surface of the large-diameter portion 11a, the large-diameter portion 11a formed slightly forward of the bottom portion 12, the small-diameter portion 11b formed in front of the large-diameter portion 11a. It is comprised by the two bulging parts 11c.
  • the holding portion 13 protrudes forward from the center of the bottom portion 12, and four ribs 13a are formed on the outer periphery thereof in the front-rear direction.
  • the cannula 3 penetrates the holding part 13 in the front-rear direction, and its rear end is located between the bottom part 12 and the rear end of the base part 11.
  • the two guide portions 14 have a substantially wedge shape protruding forward from the small diameter portion 11b of the base portion 11, and include an inclined surface 14a inclined from the front to the rear, and a vertical surface 14b formed straight in the front-rear direction. Have.
  • a part of the outer peripheral surface of the guide portion 14 bulges up to approximately the middle between the large-diameter portion 11a and the small-diameter portion 11b, and an engagement groove 14c is formed in the front-rear direction. It fits with the return prevention protrusion 35 formed in the.
  • the protection unit 5 is integrally formed of an elastic resin, and is formed so that the holding portion 13 of the hub 4 passes through the center of the protection cover 7 and the spring portion 8.
  • the protective cover 7 includes a cover portion 21 provided so as to be able to protrude and retract from the hub 4, and an engaging portion 22 provided behind the cover portion 21, and a boundary between the cover portion 21 and the engaging portion 22 is provided at the boundary between the cover portion 21 and the engaging portion 22.
  • a step is formed.
  • step difference comprises the engaging surface which comprises the stopper means for hold
  • two through holes 22a are formed on the side surface of the engaging portion 22 at opposing positions, and an engaging protrusion 24 is provided inside the through hole 22a via a deforming portion 23.
  • the engaging protrusion 24 normally protrudes outward from the outer peripheral surface of the engaging portion 22, and when the engaging protrusion 24 is pressed from the outer peripheral side, the deforming portion 23 is deformed and moves to the cannula 3 side. When the pressing force is released, it returns to its original position.
  • the spring portion 8 is connected in series to the rear end of the engagement portion 22, and the rear end abuts against the bottom portion 12 of the hub 4 to urge the protective cover 7 forward.
  • the protective cover and the spring part are separate parts, the protective cover must be provided with a spring receiving part for holding the spring part, which not only complicates the structure of the protective cover. Since the diameter of the protective cover needs to be increased or the entire length needs to be increased, the entire needle assembly is increased in size and the handling of the needle assembly becomes complicated.
  • FIG. 6 (a) to 6 (d) show the cylindrical portion 6,
  • FIG. 6 (a) is a sectional view seen from the same direction as FIG. 1, and
  • FIG. 6 (b) shows the cylindrical portion 6 in FIG.
  • FIG. 6 (c) is a front view with respect to FIG. 6 (a), and
  • FIG. 6 (d) is a cross-sectional view taken along the line dd in FIG. 6 (b).
  • FIG. 6 (a) is a cross-sectional view taken along the line aa in FIG. 6 (c).
  • a flange 31 that bulges toward the inner peripheral side is provided at the tip of the cylindrical portion 6, and two bulge portions 32 are provided at opposing positions on the outer peripheral surface, with respect to the bulge portion 32.
  • Two through holes 33 are formed at positions rotated by 90 °.
  • the flange 31 has substantially the same diameter as the cover portion 21 of the protective cover 7, and the rear surface of the flange 31 abuts on the engaging portion 22 of the protective cover 7 to hold the protective cover 7 in the forward position.
  • the engaged surface of the stopper means is configured.
  • the engagement protrusion 24 of the protective cover 7 is inserted into the through hole 33 in the post-use state. At this time, the rear end surface of the engagement protrusion 24 and the through hole 33 are engaged with each other.
  • the protective cover 7 is fixed to the hub 4 so as not to be retractable.
  • the hub 4 can be easily inserted into the cylindrical portion 6 while the bulging portion 32 and the bulging portion 11c of the hub 4 are linearly aligned.
  • the body can be assembled.
  • a groove 6a formed in the front-rear direction at a position facing the cannula 3 is formed on the inner peripheral surface of the tubular portion 6 and behind the groove 6a.
  • a step portion 6b that fits into the small diameter portion 11b of the hub 4 is formed.
  • the through-hole 33 is located at an adjacent lower position in the figure.
  • the width of the rotation prevention protrusion 34 in the groove 6a on the upper side and the lower side in the figure is formed such that the engagement protrusion 24 of the protective cover 7 can be moved, and on the inner peripheral surface on the upper side in the figure. In comparison, the inner peripheral surface on the lower side in the figure is slightly shallower.
  • the return prevention protrusion 35 includes an inclined portion 35a that gradually protrudes from the pre-use holding portion A to the post-use holding portion B toward the inner peripheral surface side, and the post-use holding portion B in the inclined portion 35a. It is comprised from the level
  • a guide means G for restricting the movement of the engaging projection 24 of the protective cover 7 is formed on the inner peripheral surface of the hub body composed of the hub 4 and the cylindrical portion 6. Specifically, when the hub 4 and the cylindrical portion 6 are connected, the vertical surface 14b of the guide portion 14 of the hub 4 is in close contact with the side surface of the groove 6a of the cylindrical portion 6, and the cylindrical portion 6 The return prevention projection 35 and the engagement groove 14c of the guide portion 14 are fitted to each other. As a result, as shown in FIGS. 4A and 4B, a pre-use holding portion A that holds the engagement protrusion 24 in the pre-use state is formed above the rotation prevention protrusion 34 in the groove 6a, thereby preventing rotation.
  • the through-hole 33 below the protrusion 34 is formed with a post-use holding portion B that engages with the engaging protrusion 24 in the pre-use state.
  • the inclined surface 14a of the guide portion 14 in the hub 4 is located behind the pre-use holding portion A and the post-use holding portion B, and the inclined surface 14a is used from the pre-use holding portion A side after use. It will arrange
  • a cartridge containing insulin contains insulin for a plurality of times, and a new needle assembly 1 must be attached to this cartridge every time insulin is injected.
  • the needle assembly 1 is equipped with the container cap 2 during storage, and the container cap 2 is sealed with a film (not shown) to prevent invasion of germs and the like.
  • the film is first removed from the container cap 2, and in this state, a cartridge or a pen-type syringe is attached to the base 11 of the hub 4, thereby protruding into the base 11.
  • the rear end of the cannula 3 is punctured at the tip of a cartridge or pen-type syringe.
  • the needle assembly 1 is exposed to the outside, and the needle assembly 1 is in a pre-use state shown in FIG.
  • the protective cover 7 is biased forward by the biasing force of the spring portion 8, the engaging portion 22 abuts against the flange 31 of the tubular portion 6 from the rear, and the protective cover 7 is positioned at the forward movement position.
  • the canula 3 is going to be surrounded.
  • the engagement protrusion 24 of the protective cover 7 is located in the pre-use holding part A in the guide means G, and the rotation preventing protrusion 34 prevents the rotation to the post-use holding part B side.
  • the engaging projection 24 moves obliquely rearward along the inclined surface 14 a of the protective cover 7, and accordingly, the entire protective unit 5 rotates around the cannula 3. Further, as shown in FIG. 7, the engaging protrusion 24 contacts the return preventing protrusion 35 of the guide means G, so that the deforming portion 23 is deformed and the engaging protrusion 24 moves to the cannula 3 side. ing.
  • the engaging protrusion 24 comes into contact with the step part 35b of the return preventing protrusion 35, so that the rotation to the holding part A before use is not performed. Be blocked. That is, once the needle assembly 1 is in use, the needle assembly 1 is not brought into the pre-use state again. Further, since the inner peripheral surface of the guide means G closer to the holding portion B after use than the return preventing protrusion 35 is located closer to the cannula 3 than the inner peripheral surface of the holding portion A before use, the engaging protrusion 24. Does not completely protrude from the engaging portion 22, and the deforming portion 23 remains elastically deformed.
  • the user When the needle assembly 1 is in use, the user performs the required operation on the cartridge to administer insulin, then retracts the syringe to remove the syringe from the patient, and the protective cover 7 is in the advanced position.
  • the state after use in FIG. At this time, when the syringe is moved backward, the protective cover 7 protrudes from the hub 4 by the urging force of the spring portion 8, and the engaging portion 22 of the protective cover 7 comes into contact with the flange 31 of the cylindrical portion 6 from the rear, so Will be held in position.
  • the spring portion 8 urges the protective cover 7 straightly toward the front, the engagement protrusion 24 moves forward from the state of FIG. Reach the holding part B.
  • the deforming portion 23 returns to its original shape, and the engaging protrusion 24 protrudes into the through hole 33 formed in the cylindrical portion 6, and the rear end of the engaging protrusion 24 comes into contact with the through hole 33. .
  • the protective cover 7 can be prevented from retreating, and the engagement protrusion 24 can penetrate the protective cover 7 even if the protective cover 7 is rotated. Since the hole 33 and the rotation preventing projection 34 are engaged, the engagement projection 24 does not rotate again to the pre-use holding portion A side.
  • the engagement protrusion 24 of the protective cover 7 is fixed so as not to be moved by the through-hole 33 once in a used state, so that the re-exposure of the cannula 3 is prevented, Reuse of the needle assembly 1 and accidental puncture accidents can be prevented.
  • the protection unit 5 is integrally formed, the number of parts can be reduced as compared with a conventional needle assembly using a metal spring, and the assembly is facilitated.
  • the protective cover 7 and the spring portion 8 in series, the shape in which the protective cover 7 and the spring portion 8 are connected is not complicated, and can be easily formed integrally. Can be miniaturized.
  • the engaging protrusion 24 of the protective cover 7 is rotated backward by the inclined surface 14a of the guide means G, and when changing from the use state to the post-use state, Since the protective cover 7 moves straight forward by the urging force of the spring portion 8, it is possible to prevent the engagement protrusion 24 from returning to the pre-use holding portion A as much as possible after use. Furthermore, since the return prevention protrusion 35 is provided between the holding part A before use and the through hole 33, the return of the engaging protrusion 24 to the holding part A before use can be prevented, and the engagement can be more reliably performed. The mating protrusion 24 can be guided to the through hole 33.
  • FIGS. 8 and 9 show a needle assembly 101 according to the second embodiment.
  • 100 is added to the reference numerals for members common to the needle assembly 1 of the first embodiment. I will explain.
  • the needle assembly 101 is connected to a hub 104 that holds the cannula 103, a protection unit 105 that moves forward and backward with respect to the hub 104 to surround the tip of the cannula 103, and the front of the hub 104.
  • a cylindrical portion 106 that surrounds the outer periphery of the protection unit 105.
  • FIG. 9 the state before use (FIG. 9A) in which the tip of the protection unit 105 is located at the forward position, the state where the engagement protrusion of the protection unit 105 is positioned at the return prevention protrusion (FIG. 9B)
  • FIG. 9C The use state in which the tip of the protection unit 105 moves to the retracted position so that the cannula 103 can puncture the patient (FIG. 9C), and the use state in which the tip of the protection unit 105 is again located at the advance position (FIG. 9D ))
  • the protective unit 105 includes a protective cover 107 that protrudes and protrudes from the cylindrical portion 106 and a spring portion 108 provided in series at the rear end of the protective cover 107.
  • a deforming portion 123 that holds the engaging protrusion 124 is provided.
  • the outer peripheral surface on the distal end side of the protective cover 107 has a tapered shape that becomes narrower toward the distal end, and this tapered shape facilitates insertion of the distal end of the protective cover 107 into the cylindrical portion 106 when the needle assembly 101 is assembled. It is like that.
  • the engaging portion 122 constituting the protective cover 107 is formed to have a larger diameter than the cover portion 121, and a stopper means for holding the protective cover 107 in the forward position at the boundary between the engaging portion 122 and the cover portion 121.
  • An inclined surface 122a constituting an engaging surface is formed.
  • the hub 104 includes a cylindrical main body 111, a bottom 112 provided inside the main body 111, and a holding portion 113 that protrudes forward from the center of the bottom 112 and holds the canula 103. Yes.
  • a large-diameter portion 111a exposed to the outside when the needle assembly 101 is used and a small-diameter portion 111b provided at the tip of the large-diameter portion 111a are formed on the outer peripheral surface of the main body portion 111.
  • These large-diameter portions On the outer peripheral surfaces of 111a and the small-diameter portion 111b, a flat surface 111c is formed at opposing positions.
  • projections 111d are formed on the flat surface 111c of the small-diameter portion 111b toward the outside, and an inclined surface is formed in front of the projection 111d. Furthermore, a threaded portion that is screwed into the cartridge is formed on the inner peripheral surface of the main body 111 behind the bottom portion 112, and the guide means G is configured in front of the bottom portion 112 so as to face the opposing portion. A wedge-shaped groove 111e is formed.
  • the cylindrical portion 106 includes a flange 131 formed at the tip and bulging toward the inner peripheral side, two flat surfaces 132 formed at opposite positions on the outer peripheral surface, and an engagement formed on the flat surface 132.
  • a joint hole 132a and two through holes 133 formed at a position rotated about 70 ° with respect to the flat surface 111c are provided.
  • a thin portion (not shown) into which the small-diameter portion 111b of the hub 104 is fitted is formed on the inner peripheral surface of the tubular portion 106, and a position facing the canula 103 in front of the thin portion.
  • the groove 106a constituting the guide means G is formed in the front-rear direction.
  • the flat surface 132 is formed so as to be aligned with the flat surface 111c of the hub 104 in a straight line.
  • the guide means G is formed on the inner peripheral surface of the hub body composed of the hub 104 and the cylindrical portion 106. Yes. Specifically, a groove 111e formed on the inner peripheral surface of the hub 104 is positioned behind the through hole 133 and the groove 106a formed in the cylindrical portion 106. The groove 106 a is formed at a position rotated by a predetermined angle with respect to the through hole 133, and the position of the tip of the groove 106 a is positioned in front of the through hole 133.
  • the groove 106a constitutes a pre-use holding portion A that holds the engaging protrusion 124 in a pre-use state, and the post-use holding portion B that the through-hole 133 engages with the engaging protrusion 124 in a post-use state.
  • An anti-rotation protrusion 134 is formed between the holding part A before use and the holding part B after use.
  • the groove 111e of the hub 104 is formed in accordance with the widths of the groove 106a and the through hole 133 of the cylindrical portion 106, and is an inclined surface that is inclined backward from the pre-use holding portion A side toward the post-use holding portion B side. 114 a is formed, and a back prevention protrusion 135 is formed behind the rotation prevention protrusion 134.
  • FIG. 9A shows a state before the needle assembly 101 is used, and the protective projection 107 of the protective cover 107 has the engaging projection 124 positioned at the holding portion A before use.
  • the cannula 103 is surrounded by the protective cover 107.
  • the engagement protrusion 124 is prevented from rotating toward the post-use holding portion B by the rotation prevention protrusion 134.
  • the protective cover 107 moves backward and FIG. 9B.
  • the tip of the cannula 103 is slightly exposed, and the engagement protrusion 124 contacts the inclined surface 114a from the front and moves obliquely backward.
  • the inclined surface 122a at the boundary of the engaging portion 122 of the protective cover 107 with the cover portion 121, when the protective cover 107 moves backward while rotating, the flange 131 of the tubular portion 106 and The friction generated between the protective cover 107 and the protective cover 107 can be smoothly retracted.
  • the protection unit 105 further moves backward while rotating, the use state shown in FIG. 9C is entered, and at this time, the engagement protrusion 124 gets over the return prevention protrusion 135. Then, when the user performs the required operation on the cartridge to administer insulin and then the syringe is retracted, the protective cover 107 is positioned at the advanced position by the urging force of the spring portion 108, and FIG. After use. At this time, the engaging protrusion 124 moves forward without rotating, moves forward to the position of the through hole 133 as the post-use holding portion B, protrudes to the outside by the elastic force of the deforming portion 123, and engages with the through hole 133. As a result, the protective cover 107 is prevented from moving backward thereafter.
  • the tip of the protective cover 107 in the post-use state is compared with the pre-use state. The position is located rearward.
  • the engagement protrusion 124 of the protective cover 107 is fixed so as not to be moved by the through-hole 133 once it is in the used state, thereby preventing re-exposure of the cannula 3.
  • the protection unit 105 is integrally formed, the number of parts can be reduced as compared with a conventional needle assembly using a metal spring, and assembly is facilitated.
  • the shape of connecting the protective cover 107 and the spring portion 108 is not complicated, and can be easily formed integrally, and the needle assembly 101 can be reduced in size. Then, when changing from the pre-use state to the use state, the engaging projection 124 of the protective cover 107 is rotated back by the inclined surface 114a of the guide means G, and when changing from the use state to the post-use state, Since the protective cover 107 moves straight forward by the urging force of the spring portion 108, it is possible to prevent the engagement protrusion 124 from returning to the pre-use holding portion A as much as possible after use.
  • the return prevention protrusion 135 is provided between the holding part A before use and the holding part B after use, it is possible to prevent the engagement protrusion 124 from returning to the holding part A before use, and more reliably.
  • the engaging protrusion 124 can be guided to the holding portion B after use.
  • FIG. 10 shows a state after use of the needle assembly 201 according to the third embodiment.
  • members common to the needle assembly 1 of the first embodiment are designated by the reference numerals. An explanation will be given by adding 200.
  • the needle assembly 201 is connected to the hub 204 that holds the cannula 203, the protection unit 205 that moves forward and backward with respect to the hub 204 to surround the tip of the cannula 203, and the front of the hub 204.
  • the cylindrical portion 206 surrounds the outer periphery of the protection unit 205, and the hub 204 and the cylindrical portion 206 are connected to form a hub body.
  • the protective cover 207 and the spring portion 208 are integrally formed in series, and a guide means G is formed on the side surface of the engaging portion 207a of the protective cover 207.
  • the cylindrical portion 206 constituting the hub body is provided with an engaging protrusion 206a that protrudes toward the inner peripheral surface, and the engaging protrusion 206a can be moved to the outer peripheral side by the deforming portion 206b.
  • the guide means G includes a pre-use holding part A (not shown) adjacent to the post-use holding part B, and the pre-use holding part in front of the post-use holding part B and the pre-use holding part A.
  • An inclined surface 207c that is inclined forward from the A side to the post-use holding part B side is formed. Further, between the post-use holding part B and the pre-use holding part A, a rotation prevention protrusion and a return prevention protrusion 207d (not shown) are formed.
  • the guide means G moves forward with respect to the engaging protrusion 206a, and the engaging protrusion 206a engages with the through hole 207b as the holding portion B after use.
  • the cover 207 is in a state after use.
  • the engagement protrusion 206a of the cylindrical portion 206 is formed by the through-hole 207b once in the post-use state. Since it is fixed so that it cannot move, re-exposure of the cannula 203 is prevented, and reuse of the needle assembly 201 and an accidental puncture can be prevented.
  • the protection unit 205 is integrally molded and the protective cover 207 and the spring portion 208 are arranged in series, the number of parts can be reduced and the integral molding can be easily performed as compared with the conventional needle assembly. And the size of the needle assembly can be reduced.
  • the protective cover 207 retreats while rotating because the engaging protrusion 206a and the inclined surface 207c of the cylindrical portion 206 are engaged, and after use from the use state.
  • the protective cover 207 moves straight forward due to the urging force of the spring portion 208, so that the engagement protrusion 206a is prevented from returning to the pre-use holding portion A after use as much as possible. Can do.
  • the return prevention protrusion 207d is provided between the holding part A before use and the through hole 207b, the return of the engaging protrusion 206a to the holding part A before use can be prevented, and the engagement is more reliably performed.
  • the mating protrusion 206a can be guided to the through hole 207b.

Abstract

A needle assembly (1) comprises a hub (4) for holding a canula (3), a protective unit (5) adapted to advance and retract and surrounding the tip of the canula (3), and a tubular section (6) for surrounding the outer periphery of the protective unit (5).  The protective unit (5) has a spring section (8) formed integrally with and in series with a protective cover (7) exposed and covered by the tubular section (6).  The hub (4) and the tubular section (6) are connected together to form a hub body. An engaging projection (24) is provided to the protective cover (7), and a guide means (G) is provided to the hub body.  When the protective cover (7) becomes retracted from a before-use state (Fig. 4 (a)) in which the protective cover (7) is located at an advanced position, the engaging projection (24) makes contact with a sloped surface (14a) and moves rearward while rotating (Fig. 4 (b)).  When the protective cover (7) becomes advanced from a use state (Fig. 4 (c)) in which the protective cover (7) is located at a retracted position, the engaging projection (24) moves forward and is fixed by an after-use holding section (B) so as not to be movable rearward. The needle assembly (1) can be produced at low cost and can be safely used.

Description

針組立体Needle assembly
 本発明は針組立体に関し、詳しくはカヌラの先端を囲繞する前進位置および上記カヌラの先端を露出させる後退位置に移動する保護カバーを備えた針組立体に関する。 The present invention relates to a needle assembly, and more particularly to a needle assembly provided with a protective cover that moves to a forward position that surrounds the tip of the cannula and a retracted position that exposes the tip of the cannula.
 従来、カヌラを保持するハブと、ハブに対して進退動して上記カヌラの先端を囲繞する前進位置および上記カヌラの先端を露出させる後退位置に位置する保護カバーと、上記ハブと保護カバーとの間に弾装されて保護カバーを前方に付勢する付勢手段と、上記保護カバーを上記前進位置に保持するストッパ手段とを備えた針組立体が知られている。
 またこの様な針組立体として、上記保護カバーが、上記前進位置に位置して上記カヌラの先端が囲繞される使用前状態と、保護カバーが上記後退位置に位置して上記カヌラの先端が露出する使用状態と、再び上記前進位置に位置してカヌラの先端が囲繞されるとともに再び後退位置へと移動しないように固定した使用後状態とに移動する針組立体も知られている(特許文献1、2)。
 特許文献1のインシュリン注射システムは、上記ハブと、該ハブの外周面を覆うように設けられた保護カバーと、ハブの内部に設けられるとともに保護カバーの先端側の底部に当接するばね部材とから構成されている。
 この特許文献1のインシュリン注射システムの場合、保護カバーの内周面に係合突起が設けられており、ハブの外周面には係合突起をガイドするガイド溝が設けられている。
 このガイド溝は、使用前状態の保護カバーを後方に押圧すると係合突起を後方に導き、カヌラが使用状態に位置すると、斜め前方に向けて形成された溝に沿って回転しながら前方に移動して使用後状態に位置するようになっている。
 この使用後状態では、突起がガイド溝に形成された凹部に嵌合するようになっており、再び保護カバーが後方に移動しないようになっている。
 特許文献2の注射針構造は、上記ハブの前方に保護カバーの外周を囲繞する筒状部と、該保護カバーの後部に設けた固定用部材と、固定用部材とハブとの間に弾装されたばね部材とから構成されている。
 この特許文献2の注射針構造の場合、筒状部の内周面、保護カバーの外周面、固定用部材の外周面にそれぞれ突起を設け、これらの突起に適宜傾斜を設ける構成となっている。
 このため、使用前状態から上記保護カバーを後退させると、上記突起の傾斜面同士が摺動しながら保護カバーが回転して使用状態となり、その後保護カバーが前方に移動すると突起の傾斜面同士がさらに摺動しながら保護カバーが回転して使用後状態に位置する。
 この使用後状態では突起と突起とが相互に当接して保護カバーの後退を阻止するようになっている。
Conventionally, a hub that holds the cannula, a forward cover that moves forward and backward relative to the hub to surround the tip of the cannula, a protective cover that is positioned at a retracted position that exposes the tip of the cannula, and the hub and the protective cover 2. Description of the Related Art A needle assembly is known that includes an urging unit that is elastically disposed therebetween and urges a protective cover forward, and a stopper unit that holds the protective cover in the advanced position.
Further, in such a needle assembly, the protective cover is in the forward position and the tip of the cannula is surrounded, and the protective cover is in the retracted position and the tip of the cannula is exposed. There is also known a needle assembly that moves between a use state to be moved and a post-use state in which the tip of the cannula is surrounded again and fixed so as not to move to the retreat position again (Patent Document). 1, 2).
The insulin injection system of Patent Document 1 includes the hub, a protective cover provided so as to cover the outer peripheral surface of the hub, and a spring member provided inside the hub and in contact with the bottom portion on the front end side of the protective cover. It is configured.
In the case of the insulin injection system of Patent Document 1, an engagement protrusion is provided on the inner peripheral surface of the protective cover, and a guide groove for guiding the engagement protrusion is provided on the outer peripheral surface of the hub.
The guide groove moves forward while rotating along the groove formed obliquely forward when the cannula is located in the use state when the protective cover in the pre-use state is pressed backward to guide the engagement protrusion backward. And it comes to be located in the state after use.
In this post-use state, the protrusion is fitted in a recess formed in the guide groove, so that the protective cover does not move backward again.
In the injection needle structure of Patent Document 2, a cylindrical portion surrounding the outer periphery of the protective cover in front of the hub, a fixing member provided at the rear portion of the protective cover, and an elastic member between the fixing member and the hub. It is comprised from the made spring member.
In the case of the injection needle structure of Patent Document 2, protrusions are provided on the inner peripheral surface of the cylindrical portion, the outer peripheral surface of the protective cover, and the outer peripheral surface of the fixing member, and these protrusions are appropriately inclined. .
For this reason, when the protective cover is retracted from the pre-use state, the protective cover rotates while sliding between the inclined surfaces of the protrusions to become in use, and then the inclined surfaces of the protrusions move when the protective cover moves forward. Further, the protective cover rotates while sliding and is positioned in the post-use state.
In this state after use, the protrusion and the protrusion come into contact with each other to prevent the protective cover from retreating.
特表2003-534105号公報Special table 2003-534105 gazette 特表2005-510308号公報JP 2005-510308 Gazette
 しかしながら、上記特許文献1のインシュリン注射システムの場合、保護カバーがハブの外周を覆うように形成されていることから、この保護カバーを保持した状態で注射器を操作することが困難であるという問題があった。
 また特許文献1のインシュリン注射システムでは、使用状態から使用後状態とする際に、ガイド溝に沿って斜めに係合突起を移動させなければならないのに対し、ばねの付勢力はまっすぐ前方に作用するので、再び使用前状態に移動してしまう可能性があった。
 一方、特許文献2の注射針構造の場合、構成部品が多数必要であり、製造コストが高くなるという問題があった。
 このような問題に鑑み、本発明は低コストに製造可能で、また安全に使用可能な針組立体を提供するものである。
However, in the case of the insulin injection system of Patent Document 1, since the protective cover is formed so as to cover the outer periphery of the hub, there is a problem that it is difficult to operate the syringe while holding the protective cover. there were.
Further, in the insulin injection system of Patent Document 1, when the use state is changed from the use state to the post-use state, the engagement protrusion must be moved obliquely along the guide groove, whereas the biasing force of the spring acts straight forward. As a result, there is a possibility of moving to the state before use again.
On the other hand, in the case of the injection needle structure disclosed in Patent Document 2, a large number of components are required, resulting in an increase in manufacturing cost.
In view of these problems, the present invention provides a needle assembly that can be manufactured at low cost and can be used safely.
 すなわち、請求項1の発明にかかる針組立体は、カヌラを保持するハブと、ハブに対して進退動して上記カヌラの先端を囲繞する前進位置および上記カヌラの先端を露出させる後退位置に位置する保護カバーと、上記ハブと保護カバーとの間に弾装されて保護カバーを前方に付勢する付勢手段と、上記保護カバーを上記前進位置に保持するストッパ手段とを備えた針組立体において、
 上記ハブに上記保護カバーの外周を囲繞する筒状部を設け、
 かつ、上記付勢手段としてのばね部を上記保護カバーに直列に整列するように設け、これら保護カバーとばね部とを弾性を有する素材で一体的に成形したことを特徴としている。
That is, the needle assembly according to the invention of claim 1 is located at a hub that holds the cannula, a forward position that moves forward and backward with respect to the hub and surrounds the tip of the cannula, and a retracted position that exposes the tip of the cannula. A needle cover provided with a protective cover, a biasing means that is elastically mounted between the hub and the protective cover and biases the protective cover forward, and a stopper means that holds the protective cover in the forward position. In
A cylindrical portion surrounding the outer periphery of the protective cover is provided on the hub,
And the spring part as said urging | biasing means was provided so that it might align in series with the said protective cover, and these protective covers and the spring part were integrally shape | molded with the raw material which has elasticity, It is characterized by the above-mentioned.
 また、請求項2の発明にかかる針組立体は、カヌラを保持するハブと、ハブに対して進退動して上記カヌラの先端を囲繞する前進位置および上記カヌラの先端を露出させる後退位置に位置する保護カバーと、上記ハブと保護カバーとの間に弾装されて保護カバーを前方に付勢する付勢手段と、上記保護カバーを上記前進位置に保持するストッパ手段とを備え、
 上記保護カバーが、上記前進位置に位置して上記カヌラの先端が囲繞される使用前状態と、保護カバーが上記後退位置に位置して上記カヌラの先端が露出する使用状態と、再び上記前進位置に位置してカヌラの先端が囲繞されるとともに再び後退位置へと移動しないように固定した使用後状態とに移動する針組立体において、
 上記ハブに上記保護カバーの外周を囲繞する筒状部を設けるとともに、これらハブと筒状部とからなるハブ体または保護カバーのいずれか一方に係合突起を、他方に該係合突起の移動を規制するガイド手段をそれぞれ設け、
 上記ガイド手段は、上記係合突起を使用前状態の位置で保持する使用前保持部と、係合突起を使用後状態の位置に固定する使用後保持部と、保護カバーを後退させると係合突起に係合して、保護カバーを上記使用前保持部側位置から使用後保持部側位置に向けて回転させながら後退させる傾斜面とを備え、
 使用前状態から付勢手段の付勢力に抗して保護カバーを後退させると、上記係合突起と傾斜面とが当接して、保護カバーが回転しながら後退して上記使用状態となり、該使用状態から保護カバーを前進させると、係合突起が上記使用後保持部に固定されて使用後状態となることを特徴としている。
Further, the needle assembly according to the invention of claim 2 is located at a hub that holds the cannula, a forward position that moves forward and backward with respect to the hub and surrounds the tip of the cannula, and a retracted position that exposes the tip of the cannula. A protective cover, a biasing means that is elastically mounted between the hub and the protective cover and biases the protective cover forward, and a stopper means that holds the protective cover in the forward position,
The pre-use state in which the protective cover is located at the forward position and the tip of the cannula is surrounded; the use state in which the protective cover is located at the retracted position and the tip of the cannula is exposed; and the forward position again In the needle assembly which is moved to the post-use state where the tip of the cannula is surrounded and fixed so as not to move to the retracted position again,
The hub is provided with a cylindrical portion that surrounds the outer periphery of the protective cover, and the engaging projection is moved to one of the hub body or the protective cover composed of the hub and the cylindrical portion, and the engaging projection is moved to the other. Each is provided with a guide means to regulate,
The guide means engages when the pre-use holding portion that holds the engaging protrusion at the pre-use position, the post-use holding portion that fixes the engaging protrusion at the post-use state, and the protective cover is retracted. An inclined surface that engages with the protrusion and retracts the protective cover while rotating from the pre-use holding unit side position toward the post-use holding unit side position,
When the protective cover is retracted against the urging force of the urging means from the pre-use state, the engaging projection and the inclined surface come into contact with each other, and the protective cover moves backward while rotating to enter the use state. When the protective cover is moved forward from the state, the engaging protrusion is fixed to the post-use holding portion to be in the post-use state.
 上記請求項1の発明によれば、筒状部を保護カバーを囲繞するように設けたことから、使用者はこの保護カバーを保持して注射をすることができる。
 また、上記保護カバーとばね部とが弾性を有する素材で一体的に成形されていることから、上記特許文献1、2に比べて部品点数を抑えることができ、かつ、保護カバーとばね部とが直列に整列しているため、これらを容易に一体成形することが可能であり、針組立体を小型化することが可能となる。
 つまり、保護カバーとばね部とを別体に成形すると、保護カバーにばね受け部を形成しなければならず、その分だけ保護カバーが大型化し、ひいては針組立体全体が大型化するという問題があった。
According to the first aspect of the present invention, since the cylindrical portion is provided so as to surround the protective cover, the user can perform injection while holding the protective cover.
In addition, since the protective cover and the spring portion are integrally formed of a material having elasticity, the number of parts can be reduced as compared with Patent Documents 1 and 2, and the protective cover and the spring portion Are aligned in series, they can be easily formed integrally, and the needle assembly can be miniaturized.
In other words, if the protective cover and the spring portion are formed separately, the spring receiving portion must be formed on the protective cover, which increases the size of the protective cover and the size of the entire needle assembly. there were.
 上記請求項2の発明によれば、筒状部が保護カバーを囲繞するように設けられていることから、使用者はこの保護カバーを保持して注射をすることができる。
 また、保護カバーを使用前位置から使用位置に移動させる際に、保護カバーは回転しながら後退するようになっているため、その後使用位置から使用後位置に移動する際には上記付勢手段の付勢力によって前方に移動するものとなっている。
 つまり、係合突起が回転して使用前保持部側へと移動しにくい構成となっており、誤作動を防止することができる。
 さらに上記特許文献2の注射針構造に比べて部品点数を抑えることができ、低コストに針組立体を製造することができる。
According to the second aspect of the invention, since the cylindrical portion is provided so as to surround the protective cover, the user can hold the protective cover and perform injection.
Further, when the protective cover is moved from the pre-use position to the use position, the protective cover is rotated and retracted. Therefore, when the protective cover is subsequently moved from the use position to the post-use position, It moves forward by the urging force.
That is, the engagement protrusion is configured to be difficult to rotate and move toward the holding unit before use, and malfunction can be prevented.
Furthermore, the number of parts can be reduced as compared with the injection needle structure of Patent Document 2, and a needle assembly can be manufactured at low cost.
第1実施例にかかる針組立体の使用前状態を示す断面図。Sectional drawing which shows the state before use of the needle assembly concerning a 1st Example. 上記針組立体の使用後状態を示す断面図。Sectional drawing which shows the state after use of the said needle assembly. 針組立体の構成部品を示す構成図。The block diagram which shows the component of a needle assembly. 針組立体の動作を示す図であって、(a)は使用前状態を、(b)は使用前状態と使用状態との中間の状態を、(c)は使用状態を、(d)は使用後状態をそれぞれ示す。It is a figure which shows operation | movement of a needle | hook assembly, Comprising: (a) is a state before use, (b) is an intermediate state between the state before use and a use state, (c) is a use state, (d) is a state. Each state after use is shown. 本体部を示す図であって、(a)は図1のV-V方向から見た側面図を、(b)は(a)に対する正面図を、(c)は(b)のc-c部で切断した断面図をそれぞれ示す。2A and 2B are views showing a main body, in which FIG. 1A is a side view seen from the direction VV in FIG. 1, FIG. 2B is a front view with respect to FIG. 1A, and FIG. Sectional drawing cut | disconnected by the part is each shown. 筒状部を示す図であって、(a)は図1と同じ方向からみた断面図を、(b)は図1のV-V方向から見た側面図を、(c)は(a)に対する正面図を、(d)は(b)のd-d部で切断した断面図をそれぞれ示している。2A and 2B are views showing a cylindrical portion, in which FIG. 1A is a cross-sectional view seen from the same direction as FIG. 1, FIG. 1B is a side view seen from the direction VV in FIG. (D) is a cross-sectional view taken along a line dd in (b). 図4(b)における係合突起とガイド手段との関係を示した図。The figure which showed the relationship between the engagement protrusion and guide means in FIG.4 (b). 第2実施例にかかる針組立体の構成部品を示す構成図。The block diagram which shows the component of the needle | hook assembly concerning a 2nd Example. 第2実施例にかかる針組立体の動作を示す図であって、(a)は使用前状態を、(b)は使用前状態と使用状態との中間の状態を、(c)は使用状態を、(d)は使用後状態をそれぞれ示す。It is a figure which shows operation | movement of the needle | hook assembly concerning 2nd Example, Comprising: (a) is a state before use, (b) is an intermediate state between the state before use and a use state, (c) is a use state. (D) shows the state after use. 第3実施例にかかる針組立体の使用後状態を示す断面図。Sectional drawing which shows the state after use of the needle | hook assembly concerning 3rd Example.
 以下、図示実施例について説明すると、図1~図3は第1実施例にかかるインシュリン注射に用いる針組立体1を示し、図1は使用前状態の針組立体1を、図2は使用後状態の針組立体1を、図3は針組立体1の分解図をそれぞれ示し、図1の針組立体1には保管時や搬送時に用いるコンテナキャップ2が装着されている。
 上記針組立体1は図示しないインシュリンを収容したカートリッジの先端に装着され、以下の説明において前方もしくは先端とは図1、図2における図示右方の患者側を、後方もしくは後端とは図示左方の上記カートリッジ側をそれぞれ指すものとする。
 針組立体1は、カヌラ3を保持するハブ4と、ハブ4に対して進退動して上記カヌラ3の先端を囲繞する保護ユニット5と、ハブ4の前方に連結されて上記保護ユニット5の外周を囲繞する筒状部6とから構成されている。
 このうち上記保護ユニット5は、上記筒状部6より出没する保護カバー7と、該保護カバー7の後端に直列に設けられたばね部8とから構成され、上記ハブ4と筒状部6とは連結することでハブ体を構成するようになっている。
 図4の各図に示すように、本実施例の針組立体1は、保護ユニット5の先端が前進位置に位置した使用前状態(図4(a))と、保護ユニット5の先端が後退位置に移動してカヌラ3が患者に穿刺可能な使用状態(図4(c))と、保護ユニット5の先端が再び前進位置に位置した使用後状態(図4(d))とに変化可能となっている。
 そして上記使用後状態になると、その後は保護ユニット5がハブ体に固定されて後退できないようになっており、これにより針組立体1の再使用を防止するとともに、カヌラ3の露出による誤穿刺事故を防止することができる。
1 to 3 show a needle assembly 1 used for insulin injection according to the first embodiment, FIG. 1 shows a needle assembly 1 in a pre-use state, and FIG. 2 shows a post-use needle assembly 1. 3 shows an exploded view of the needle assembly 1, and FIG. 3 shows an exploded view of the needle assembly 1. The needle assembly 1 shown in FIG.
The needle assembly 1 is attached to the tip of a cartridge containing insulin (not shown). In the following description, the front or tip is the patient side on the right in FIG. 1 and FIG. Each of the cartridge sides is indicated.
The needle assembly 1 includes a hub 4 that holds the cannula 3, a protection unit 5 that moves forward and backward with respect to the hub 4 and surrounds the tip of the cannula 3, and is connected to the front of the hub 4. It is comprised from the cylindrical part 6 which surrounds an outer periphery.
Of these, the protection unit 5 includes a protection cover 7 that protrudes and protrudes from the cylindrical portion 6, and a spring portion 8 provided in series at the rear end of the protection cover 7, and includes the hub 4, the cylindrical portion 6, and the like. Are configured to constitute a hub body.
As shown in FIGS. 4A and 4B, the needle assembly 1 of the present embodiment is in a pre-use state (FIG. 4A) in which the front end of the protection unit 5 is positioned at the advanced position, and the front end of the protection unit 5 is retracted. It is possible to change between a use state in which the cannula 3 can puncture the patient by moving to the position (FIG. 4C) and a post-use state in which the tip of the protection unit 5 is positioned at the advanced position again (FIG. 4D). It has become.
Then, after entering the above-mentioned state, the protection unit 5 is fixed to the hub body so that it cannot be retracted. This prevents the needle assembly 1 from being reused and causes an accidental puncture accident due to the exposure of the cannula 3. Can be prevented.
 図5(a)~(c)は上記ハブ4を示し、図5(a)は上記ハブ4を図1のV-V方向から見た側面図を、図5(b)は図5(a)に対する正面図を、図5(c)は図5(b)のc-c部で切断した断面図をそれぞれ示している。
 ハブ4は、上記カートリッジに連結される筒状の基部11と、該基部11の前後方向略中央に設けられた底部12と、該底部12の中央から前方に突出して上記カヌラ3を保持する保持部13と、上記基部11から前方に突出する2つのガイド部14とから構成されている。
 上記基部11における上記底部12よりも後方には、内周面に上記カートリッジに螺合するねじ部が形成され、底部12の前方には上記保護ユニット5のばね部8の後端が当接するようになっている(図1参照)。
 また基部11は、上記底部12よりも若干前方まで形成された大径部11aと、該大径部11aの前方に形成された小径部11bと、上記大径部11aの外周面に設けられた2つの膨出部11cとによって構成されている。
 上記保持部13は上記底部12の中央から前方に突出し、その外周には前後方向に4つのリブ13aが形成されている。上記カヌラ3は上記保持部13を前後方向に貫通し、その後端は上記底部12と基部11の後端との間に位置している。
 上記2つのガイド部14は基部11の小径部11bから前方に突出した略楔形形状を有し、前方から後方に向けて傾斜する傾斜面14aと、前後方向にまっすぐ形成された垂直面14bとを有している。
 また、ガイド部14の外周面の一部は上記大径部11aと小径部11bとの略中間まで膨出するとともに、前後方向に係合溝14cが形成されており、後述する筒状部6に形成された戻り防止突起35と嵌合するようになっている。
5 (a) to 5 (c) show the hub 4, FIG. 5 (a) is a side view of the hub 4 seen from the direction VV in FIG. 1, and FIG. 5C is a cross-sectional view taken along the line cc of FIG. 5B.
The hub 4 includes a cylindrical base portion 11 connected to the cartridge, a bottom portion 12 provided substantially at the center in the front-rear direction of the base portion 11, and a holder that protrudes forward from the center of the bottom portion 12 and holds the canula 3. A portion 13 and two guide portions 14 projecting forward from the base portion 11 are configured.
A screw part that is screwed into the cartridge is formed on the inner peripheral surface of the base part 11 behind the bottom part 12, and the rear end of the spring part 8 of the protection unit 5 is in contact with the front part of the bottom part 12. (See FIG. 1).
The base 11 is provided on the outer peripheral surface of the large-diameter portion 11a, the large-diameter portion 11a formed slightly forward of the bottom portion 12, the small-diameter portion 11b formed in front of the large-diameter portion 11a. It is comprised by the two bulging parts 11c.
The holding portion 13 protrudes forward from the center of the bottom portion 12, and four ribs 13a are formed on the outer periphery thereof in the front-rear direction. The cannula 3 penetrates the holding part 13 in the front-rear direction, and its rear end is located between the bottom part 12 and the rear end of the base part 11.
The two guide portions 14 have a substantially wedge shape protruding forward from the small diameter portion 11b of the base portion 11, and include an inclined surface 14a inclined from the front to the rear, and a vertical surface 14b formed straight in the front-rear direction. Have.
In addition, a part of the outer peripheral surface of the guide portion 14 bulges up to approximately the middle between the large-diameter portion 11a and the small-diameter portion 11b, and an engagement groove 14c is formed in the front-rear direction. It fits with the return prevention protrusion 35 formed in the.
 上記保護ユニット5は弾性を有する樹脂によって一体成形され、保護カバー7およびばね部8の中央を上記ハブ4の保持部13が貫通するように形成されている。
 保護カバー7はハブ4より出没可能に設けられたカバー部21と、該カバー部21の後方に設けられた係合部22とから構成され、カバー部21と係合部22との境界には段差が形成されている。この段差は保護カバー7を前進位置に保持するためのストッパ手段を構成する係合面を構成している。
 また、上記係合部22の側面には対向する位置に2つの貫通孔22aが形成されており、該貫通孔22aの内部には変形部23を介して係合突起24が設けられている。
 この係合突起24は通常上記係合部22の外周面より外方に突出ており、係合突起24が外周側から押圧されると、上記変形部23が変形してカヌラ3側に移動し、押圧力が解除されるともとの位置に復帰するようになっている。
 上記ばね部8は上記係合部22の後端に直列に連結されるとともに、その後端は上記ハブ4の底部12に当接し、上記保護カバー7を前方に付勢するようになっている。
 ばね部8を保護カバー7の後端に直列に連結した構成とすることで、保護カバー7とばね部8とを容易に一体成形することが可能であり、針組立体を小型化することができ、かつ取り扱いを容易にすることができる。
 具体的には、保護カバーとばね部とを別部品とした場合、保護カバーにはばね部を保持するためのばね受け部を形成しなければならないが、保護カバーの構造が複雑となるばかりか、保護カバーの径を大径としたり全長を長くする必要があるため、針組立体全体も大型化し、針組立体の取り扱いが煩雑になる問題があった。
The protection unit 5 is integrally formed of an elastic resin, and is formed so that the holding portion 13 of the hub 4 passes through the center of the protection cover 7 and the spring portion 8.
The protective cover 7 includes a cover portion 21 provided so as to be able to protrude and retract from the hub 4, and an engaging portion 22 provided behind the cover portion 21, and a boundary between the cover portion 21 and the engaging portion 22 is provided at the boundary between the cover portion 21 and the engaging portion 22. A step is formed. This level | step difference comprises the engaging surface which comprises the stopper means for hold | maintaining the protective cover 7 in an advance position.
In addition, two through holes 22a are formed on the side surface of the engaging portion 22 at opposing positions, and an engaging protrusion 24 is provided inside the through hole 22a via a deforming portion 23.
The engaging protrusion 24 normally protrudes outward from the outer peripheral surface of the engaging portion 22, and when the engaging protrusion 24 is pressed from the outer peripheral side, the deforming portion 23 is deformed and moves to the cannula 3 side. When the pressing force is released, it returns to its original position.
The spring portion 8 is connected in series to the rear end of the engagement portion 22, and the rear end abuts against the bottom portion 12 of the hub 4 to urge the protective cover 7 forward.
By adopting a configuration in which the spring portion 8 is connected in series to the rear end of the protective cover 7, the protective cover 7 and the spring portion 8 can be easily integrally formed, and the needle assembly can be downsized. And can be handled easily.
Specifically, when the protective cover and the spring part are separate parts, the protective cover must be provided with a spring receiving part for holding the spring part, which not only complicates the structure of the protective cover. Since the diameter of the protective cover needs to be increased or the entire length needs to be increased, the entire needle assembly is increased in size and the handling of the needle assembly becomes complicated.
 図6(a)~(d)は上記筒状部6を示し、図6(a)は図1と同じ方向からみた断面図を、図6(b)は筒状部6を図1のV-V方向から見た側面図を、図6(c)は図6(a)に対する正面図を、図6(d)は図6(b)のd-d部で切断した断面図をそれぞれ示している。なお、図6(a)は図6(c)におけるa-a部の断面図を示す。
 筒状部6の先端には内周側に膨出するフランジ31が設けられ、また外周面には、対向する位置に2つの膨出部32が設けられるとともに、該膨出部32に対して90°回転した位置には2つの貫通孔33が穿設されている。
 上記フランジ31は保護カバー7のカバー部21と略同径となっており、このフランジ31の後方の面は、上記保護カバー7の係合部22と当接して保護カバー7を前進位置に保持するストッパ手段の被係合面を構成している。
 上記貫通孔33には、上記使用後状態において上記保護カバー7の係合突起24が挿入されるようになっており、このとき係合突起24の後端面と貫通孔33とが相互に係合して、保護カバー7はハブ4に後退不可に固定されることとなる。
 そして、上記膨出部32を設けることにより、該膨出部32と上記ハブ4の膨出部11cとを直線状に整列させながらハブ4を筒状部6に挿入すれば、容易に上記ハブ体を組み立てることができるようになっている。
6 (a) to 6 (d) show the cylindrical portion 6, FIG. 6 (a) is a sectional view seen from the same direction as FIG. 1, and FIG. 6 (b) shows the cylindrical portion 6 in FIG. FIG. 6 (c) is a front view with respect to FIG. 6 (a), and FIG. 6 (d) is a cross-sectional view taken along the line dd in FIG. 6 (b). ing. FIG. 6 (a) is a cross-sectional view taken along the line aa in FIG. 6 (c).
A flange 31 that bulges toward the inner peripheral side is provided at the tip of the cylindrical portion 6, and two bulge portions 32 are provided at opposing positions on the outer peripheral surface, with respect to the bulge portion 32. Two through holes 33 are formed at positions rotated by 90 °.
The flange 31 has substantially the same diameter as the cover portion 21 of the protective cover 7, and the rear surface of the flange 31 abuts on the engaging portion 22 of the protective cover 7 to hold the protective cover 7 in the forward position. The engaged surface of the stopper means is configured.
The engagement protrusion 24 of the protective cover 7 is inserted into the through hole 33 in the post-use state. At this time, the rear end surface of the engagement protrusion 24 and the through hole 33 are engaged with each other. Thus, the protective cover 7 is fixed to the hub 4 so as not to be retractable.
By providing the bulging portion 32, the hub 4 can be easily inserted into the cylindrical portion 6 while the bulging portion 32 and the bulging portion 11c of the hub 4 are linearly aligned. The body can be assembled.
 図6(d)に示すように、筒状部6の内周面には、カヌラ3を挟んで対向する位置に前後方向に向けて形成された溝6aと、該溝6aの後方に形成されるとともに、上記ハブ4の小径部11bに嵌合する段差部6bとが形成されている。
 上記溝6aの先端には、上記保護カバー7が前進位置に位置した際に、上記係合突起24が位置するようになっており、その後端は上記段差部6bにそのまま開口するようになっている。
 上記溝6aの先端部中央には、内周面側に突出した回転防止突起34が設けられ、該回転防止突起34の後方には戻り防止突起35が形成されており、上記回転防止突起34に隣接する図示下方位置には上記貫通孔33が位置している。
 上記溝6aにおける回転防止突起34の図示上方側および図示下方側の幅は、上記保護カバー7の係合突起24が移動可能な幅で形成されており、また上記図示上方側の内周面に比べ、図示下方側の内周面のほうが若干浅く形成されている。
 上記戻り防止突起35は、図7に示すように使用前保持部Aから使用後保持部Bへと徐々に内周面側に突出する傾斜部35aと、該傾斜部35aにおける使用後保持部B側に隣接した位置に形成された段差部35bとから構成されている。
As shown in FIG. 6 (d), a groove 6a formed in the front-rear direction at a position facing the cannula 3 is formed on the inner peripheral surface of the tubular portion 6 and behind the groove 6a. In addition, a step portion 6b that fits into the small diameter portion 11b of the hub 4 is formed.
When the protective cover 7 is positioned at the forward position, the engagement protrusion 24 is positioned at the front end of the groove 6a, and the rear end opens as it is to the stepped portion 6b. Yes.
An anti-rotation protrusion 34 protruding toward the inner peripheral surface is provided at the center of the tip of the groove 6a, and a return prevention protrusion 35 is formed behind the anti-rotation protrusion 34. The through-hole 33 is located at an adjacent lower position in the figure.
The width of the rotation prevention protrusion 34 in the groove 6a on the upper side and the lower side in the figure is formed such that the engagement protrusion 24 of the protective cover 7 can be moved, and on the inner peripheral surface on the upper side in the figure. In comparison, the inner peripheral surface on the lower side in the figure is slightly shallower.
As shown in FIG. 7, the return prevention protrusion 35 includes an inclined portion 35a that gradually protrudes from the pre-use holding portion A to the post-use holding portion B toward the inner peripheral surface side, and the post-use holding portion B in the inclined portion 35a. It is comprised from the level | step-difference part 35b formed in the position adjacent to the side.
 そして、上記ハブ4と筒状部6とからなるハブ体の内周面には、上記保護カバー7の係合突起24の移動を規制するガイド手段Gが形成されるようになっている。
 具体的には、上記ハブ4と筒状部6とを連結すると、上記筒状部6の溝6aの側面に上記ハブ4におけるガイド部14の垂直面14bが密着し、さらに筒状部6の戻り防止突起35とガイド部14の係合溝14cとが相互に嵌合するようになっている。
 その結果、図4の各図に示すように、上記溝6aにおける上記回転防止突起34の上方には、使用前状態において上記係合突起24を保持する使用前保持部Aが形成され、回転防止突起34の図示下方の貫通孔33は、使用後前状態において上記係合突起24と係合する使用後保持部Bが形成されている。
 そして、上記ハブ4におけるガイド部14の傾斜面14aは、上記使用前保持部Aおよび使用後保持部Bの後方に位置することとなり、また上記傾斜面14aは使用前保持部A側から使用後保持部B側にかけて後方へと傾斜するように配置されることとなる。
A guide means G for restricting the movement of the engaging projection 24 of the protective cover 7 is formed on the inner peripheral surface of the hub body composed of the hub 4 and the cylindrical portion 6.
Specifically, when the hub 4 and the cylindrical portion 6 are connected, the vertical surface 14b of the guide portion 14 of the hub 4 is in close contact with the side surface of the groove 6a of the cylindrical portion 6, and the cylindrical portion 6 The return prevention projection 35 and the engagement groove 14c of the guide portion 14 are fitted to each other.
As a result, as shown in FIGS. 4A and 4B, a pre-use holding portion A that holds the engagement protrusion 24 in the pre-use state is formed above the rotation prevention protrusion 34 in the groove 6a, thereby preventing rotation. The through-hole 33 below the protrusion 34 is formed with a post-use holding portion B that engages with the engaging protrusion 24 in the pre-use state.
The inclined surface 14a of the guide portion 14 in the hub 4 is located behind the pre-use holding portion A and the post-use holding portion B, and the inclined surface 14a is used from the pre-use holding portion A side after use. It will arrange | position so that it may incline toward the holding | maintenance part B side.
 以下、上記構成を有する針組立体1の取り扱いについて説明する。
 まず、インシュリンを収容したカートリッジには複数回分のインシュリンが収容されており、このカートリッジにはインシュリン注射を行うたびに新たな針組立体1を装着しなければならない。
 針組立体1は、図1に示すように保管時には上記コンテナキャップ2が装着されており、このコンテナキャップ2は図示しないフィルムによって密閉され、内部への雑菌等の侵入が防止されている。
 針組立体1を使用する際には、最初に上記フィルムをコンテナキャップ2から除去し、その状態でカートリッジまたはペン型シリンジをハブ4の基部11に装着し、これにより基部11の内部に突出するカヌラ3の後端部がカートリッジやペン型シリンジの先端に穿刺される。
 その後、上記コンテナキャップ2を取り外すことで、針組立体1が外部に露出し、針組立体1は図4(a)に示す使用前状態となる。
 このとき、保護カバー7はばね部8の付勢力によって前方に付勢されており、係合部22が筒状部6のフランジ31に後方から当接して、保護カバー7が前進位置に位置してカヌラ3を囲繞するようになっている。
 また、保護カバー7の係合突起24は上記ガイド手段Gにおける使用前保持部Aに位置しており、かつ上記回転防止突起34によって使用後保持部B側への回転が阻止されている。
Hereinafter, the handling of the needle assembly 1 having the above configuration will be described.
First, a cartridge containing insulin contains insulin for a plurality of times, and a new needle assembly 1 must be attached to this cartridge every time insulin is injected.
As shown in FIG. 1, the needle assembly 1 is equipped with the container cap 2 during storage, and the container cap 2 is sealed with a film (not shown) to prevent invasion of germs and the like.
When using the needle assembly 1, the film is first removed from the container cap 2, and in this state, a cartridge or a pen-type syringe is attached to the base 11 of the hub 4, thereby protruding into the base 11. The rear end of the cannula 3 is punctured at the tip of a cartridge or pen-type syringe.
Then, by removing the container cap 2, the needle assembly 1 is exposed to the outside, and the needle assembly 1 is in a pre-use state shown in FIG.
At this time, the protective cover 7 is biased forward by the biasing force of the spring portion 8, the engaging portion 22 abuts against the flange 31 of the tubular portion 6 from the rear, and the protective cover 7 is positioned at the forward movement position. The canula 3 is going to be surrounded.
Further, the engagement protrusion 24 of the protective cover 7 is located in the pre-use holding part A in the guide means G, and the rotation preventing protrusion 34 prevents the rotation to the post-use holding part B side.
 次に、図4(a)の状態から患者本人または医療従事者(以下、使用者という。)が筒状部6を把持しながら注射器を患者の皮膚に対して略垂直方向に押し当てると、保護カバー7はばね部8の付勢力に抗してハブ4に対して相対的に後退し、図4(b)に示すようにカヌラ3の先端が若干露出する。
 ここで、保護カバー7を患者の皮膚に押し当てると、最初、保護カバー7は後方にまっすぐ後退するが、その後直ちに係合突起24がガイド手段Gの傾斜面14aに前方から当接する。
 すると、保護カバー7は上記傾斜面14aに沿って係合突起24が斜め後方に移動することとなり、これに伴って保護ユニット5全体がカヌラ3を中心に回転するようになっている。
 また、図7に示すように上記係合突起24は上記ガイド手段Gの戻り防止突起35に当接するため、上記変形部23が変形して係合突起24はカヌラ3側に移動するようになっている。
Next, when the patient himself or a medical worker (hereinafter referred to as a user) presses the syringe against the patient's skin in a substantially vertical direction while holding the cylindrical portion 6 from the state of FIG. The protective cover 7 moves backward relative to the hub 4 against the urging force of the spring portion 8, and the tip of the cannula 3 is slightly exposed as shown in FIG. 4 (b).
Here, when the protective cover 7 is pressed against the patient's skin, the protective cover 7 initially recedes straight back, but immediately thereafter, the engaging protrusion 24 comes into contact with the inclined surface 14a of the guide means G from the front.
Then, the engaging projection 24 moves obliquely rearward along the inclined surface 14 a of the protective cover 7, and accordingly, the entire protective unit 5 rotates around the cannula 3.
Further, as shown in FIG. 7, the engaging protrusion 24 contacts the return preventing protrusion 35 of the guide means G, so that the deforming portion 23 is deformed and the engaging protrusion 24 moves to the cannula 3 side. ing.
 図4(b)の状態からさらに針組立体1を患者側に押圧すると、保護カバー7が完全に後退してカヌラ3が完全に露出し、図4(c)に示す使用状態となる。
 このとき、保護カバー7はばね部8の付勢力に抗してさらに後退し、これに伴って上記係合突起24は上記傾斜面14aに沿ってさらに斜め後方に回転しながら移動し、保護ユニット5全体がカヌラ3を中心に回転する。
 そして、保護カバー7の先端が筒状部6の先端まで後退して後退位置に達すると、上記係合突起24は戻り防止突起35を乗越え、係合突起24は変形部23によって再び外周側に突出する。
 これにより、これ以降保護カバー7を使用前保持部A側に回転させようとしても、係合突起24が戻り防止突起35の段差部35bに当接するため、使用前保持部A側への回転は阻止される。
 つまり、一度使用状態となったら、針組立体1は再び使用前状態とはならないようになっている。
 さらに、ガイド手段Gにおける戻り防止突起35よりも使用後保持部B側の内周面は、使用前保持部A側の内周面よりもカヌラ3側に位置しているため、係合突起24は係合部22から完全に突出しておらず、変形部23は弾性変形したままとなっている。
When the needle assembly 1 is further pressed toward the patient from the state of FIG. 4B, the protective cover 7 is completely retracted and the cannula 3 is completely exposed, and the use state shown in FIG. 4C is obtained.
At this time, the protective cover 7 is further retracted against the urging force of the spring portion 8, and accordingly, the engaging projection 24 moves while rotating further obliquely rearward along the inclined surface 14a. The whole 5 rotates around the cannula 3.
When the front end of the protective cover 7 is retracted to the front end of the cylindrical portion 6 and reaches the retracted position, the engagement protrusion 24 gets over the return prevention protrusion 35, and the engagement protrusion 24 is returned to the outer peripheral side by the deformable portion 23. Protruding.
Thereby, even if it tries to rotate the protective cover 7 to the holding part A before use thereafter, the engaging protrusion 24 comes into contact with the step part 35b of the return preventing protrusion 35, so that the rotation to the holding part A before use is not performed. Be blocked.
That is, once the needle assembly 1 is in use, the needle assembly 1 is not brought into the pre-use state again.
Further, since the inner peripheral surface of the guide means G closer to the holding portion B after use than the return preventing protrusion 35 is located closer to the cannula 3 than the inner peripheral surface of the holding portion A before use, the engaging protrusion 24. Does not completely protrude from the engaging portion 22, and the deforming portion 23 remains elastically deformed.
 そして、針組立体1が使用状態となったら、使用者はカートリッジに所要の操作を行ってインシュリンの投与を行い、その後、注射器を後退させて患者から注射器を除去し、保護カバー7が前進位置に位置した図4(d)の使用後状態となる。
 このとき、注射器を後退させると、保護カバー7はばね部8の付勢力によってハブ4から突出し、保護カバー7の係合部22が筒状部6のフランジ31に後方から当接して、上記前進位置に保持されることとなる。
 ここで、ばね部8は保護カバー7を前方に向けてまっすぐに付勢しているので、係合突起24は上記図4(c)の状態から前方に移動して、ガイド手段Gの使用後保持部Bに到達する。
 すると、変形部23が元の形状に復帰して係合突起24は筒状部6に形成された貫通孔33内に突出し、係合突起24の後端が貫通孔33に当接するようになる。
 その結果、その後保護カバー7に前方からの付勢力が作用しても、上記保護カバー7の後退を阻止することができ、また保護カバー7を回転させようとしても、係合突起24は上記貫通孔33や上記回転防止突起34に係合するため、係合突起24が再び使用前保持部A側に回転することはない。
When the needle assembly 1 is in use, the user performs the required operation on the cartridge to administer insulin, then retracts the syringe to remove the syringe from the patient, and the protective cover 7 is in the advanced position. The state after use in FIG.
At this time, when the syringe is moved backward, the protective cover 7 protrudes from the hub 4 by the urging force of the spring portion 8, and the engaging portion 22 of the protective cover 7 comes into contact with the flange 31 of the cylindrical portion 6 from the rear, so Will be held in position.
Here, since the spring portion 8 urges the protective cover 7 straightly toward the front, the engagement protrusion 24 moves forward from the state of FIG. Reach the holding part B.
Then, the deforming portion 23 returns to its original shape, and the engaging protrusion 24 protrudes into the through hole 33 formed in the cylindrical portion 6, and the rear end of the engaging protrusion 24 comes into contact with the through hole 33. .
As a result, even if an urging force from the front acts on the protective cover 7 thereafter, the protective cover 7 can be prevented from retreating, and the engagement protrusion 24 can penetrate the protective cover 7 even if the protective cover 7 is rotated. Since the hole 33 and the rotation preventing projection 34 are engaged, the engagement projection 24 does not rotate again to the pre-use holding portion A side.
 上記構成を有する針組立体1によれば、一旦使用後状態になると、保護カバー7の上記係合突起24が貫通孔33によって移動不可に固定されるので、カヌラ3の再露出が阻止され、針組立体1の再利用や誤穿刺事故を防止することができる。
 また、上記保護ユニット5を一体成形しているため、従来の金属製のばねを用いる針組立体に比べて部品点数を抑えることができ、また組み立ても容易となる。
 さらに、上記保護カバー7とばね部8とを直列に配置することで、保護カバー7とばね部8とを連結した形状は複雑とならず、一体成形を容易に行うことができ、針組立体を小型化することができる。
 そして、使用前状態から使用状態にする際には、保護カバー7の係合突起24がガイド手段Gの傾斜面14aによって回転しながら後退し、かつ使用状態から使用後状態にする際には、保護カバー7はばね部8の付勢力によってまっすぐ前方に移動するので、使用後に係合突起24が使用前保持部Aへと戻ってしまうのを可及的に阻止することができる。
 さらに、上記使用前保持部Aと貫通孔33との間に戻り防止突起35を設けているので、係合突起24の使用前保持部Aへの戻りを阻止することができ、より確実に係合突起24を貫通孔33まで導くことができる。
According to the needle assembly 1 having the above-described configuration, the engagement protrusion 24 of the protective cover 7 is fixed so as not to be moved by the through-hole 33 once in a used state, so that the re-exposure of the cannula 3 is prevented, Reuse of the needle assembly 1 and accidental puncture accidents can be prevented.
Further, since the protection unit 5 is integrally formed, the number of parts can be reduced as compared with a conventional needle assembly using a metal spring, and the assembly is facilitated.
Furthermore, by arranging the protective cover 7 and the spring portion 8 in series, the shape in which the protective cover 7 and the spring portion 8 are connected is not complicated, and can be easily formed integrally. Can be miniaturized.
Then, when changing from the pre-use state to the use state, the engaging protrusion 24 of the protective cover 7 is rotated backward by the inclined surface 14a of the guide means G, and when changing from the use state to the post-use state, Since the protective cover 7 moves straight forward by the urging force of the spring portion 8, it is possible to prevent the engagement protrusion 24 from returning to the pre-use holding portion A as much as possible after use.
Furthermore, since the return prevention protrusion 35 is provided between the holding part A before use and the through hole 33, the return of the engaging protrusion 24 to the holding part A before use can be prevented, and the engagement can be more reliably performed. The mating protrusion 24 can be guided to the through hole 33.
 次に、図8、図9は第2実施例にかかる針組立体101を示し、以下の説明において、上記第1実施例の針組立体1と共通する部材についてはその符号に100を加算して説明する。
 図8に示すように、針組立体101は、カヌラ103を保持するハブ104と、ハブ104に対して進退動して上記カヌラ103の先端を囲繞する保護ユニット105と、ハブ104の前方に連結されて上記保護ユニット105の外周を囲繞する筒状部106とから構成されている。
 上記ハブ104および筒状部106とは連結することでハブ体を構成し、その内周面には上記保護カバー107の係合突起124の移動を規制するガイド手段Gが形成されている。
 そして図9では、保護ユニット105の先端が前進位置に位置した使用前状態(図9(a))、保護ユニット105の係合突起が戻り防止突起に位置した状態(図9(b))、保護ユニット105の先端が後退位置に移動してカヌラ103が患者に穿刺可能な使用状態(図9(c))、保護ユニット105の先端が再び前進位置に位置した使用後状態(図9(d))をそれぞれ示している。
Next, FIGS. 8 and 9 show a needle assembly 101 according to the second embodiment. In the following description, 100 is added to the reference numerals for members common to the needle assembly 1 of the first embodiment. I will explain.
As shown in FIG. 8, the needle assembly 101 is connected to a hub 104 that holds the cannula 103, a protection unit 105 that moves forward and backward with respect to the hub 104 to surround the tip of the cannula 103, and the front of the hub 104. And a cylindrical portion 106 that surrounds the outer periphery of the protection unit 105.
The hub 104 and the tubular portion 106 are connected to form a hub body, and guide means G for restricting the movement of the engaging projection 124 of the protective cover 107 is formed on the inner peripheral surface thereof.
In FIG. 9, the state before use (FIG. 9A) in which the tip of the protection unit 105 is located at the forward position, the state where the engagement protrusion of the protection unit 105 is positioned at the return prevention protrusion (FIG. 9B) The use state in which the tip of the protection unit 105 moves to the retracted position so that the cannula 103 can puncture the patient (FIG. 9C), and the use state in which the tip of the protection unit 105 is again located at the advance position (FIG. 9D )) Respectively.
 上記保護ユニット105は、上記筒状部106より出没する保護カバー107と、該保護カバー107の後端に直列に設けられたばね部108とから構成され、上記保護カバー107には係合突起124と該係合突起124を保持する変形部123とが設けられている。
 上記保護カバー107の先端側外周面は先端に向けて細くなるテーパ形状を有しており、このテーパ形状により針組立体101の組立て時に保護カバー107の先端を上記筒状部106に挿入しやすいようになっている。
 また保護カバー107を構成する係合部122は、カバー部121よりも大径に形成され、これら係合部122におけるカバー部121との境界には、保護カバー107を前進位置に保持するストッパ手段としての係合面を構成する傾斜面122aが形成されている。
The protective unit 105 includes a protective cover 107 that protrudes and protrudes from the cylindrical portion 106 and a spring portion 108 provided in series at the rear end of the protective cover 107. A deforming portion 123 that holds the engaging protrusion 124 is provided.
The outer peripheral surface on the distal end side of the protective cover 107 has a tapered shape that becomes narrower toward the distal end, and this tapered shape facilitates insertion of the distal end of the protective cover 107 into the cylindrical portion 106 when the needle assembly 101 is assembled. It is like that.
Further, the engaging portion 122 constituting the protective cover 107 is formed to have a larger diameter than the cover portion 121, and a stopper means for holding the protective cover 107 in the forward position at the boundary between the engaging portion 122 and the cover portion 121. An inclined surface 122a constituting an engaging surface is formed.
 ハブ104は、筒状の本体部111と、該本体部111の内部に設けられた底部112と、該底部112の中央から前方に突出して上記カヌラ103を保持する保持部113とから構成されている。
 上記本体部111の外周面には、針組立体101の使用時に外部に露出する大径部111aと、該大径部111aの先端に設けられた小径部111bとが形成され、これら大径部111aおよび小径部111bの外周面には、対向する位置に平坦面111cが形成されている。
 また、上記小径部111bの平坦面111cには、外部に向けてそれぞれ突起111dが形成されており、該突起111dの前方には傾斜面が形成されている。
 さらに、上記本体部111の内周面には、上記底部112の後方に上記カートリッジに螺合するねじ部が形成され、底部112の前方には、対向する位置に上記ガイド手段Gを構成する略楔形の溝111eが形成されている。
The hub 104 includes a cylindrical main body 111, a bottom 112 provided inside the main body 111, and a holding portion 113 that protrudes forward from the center of the bottom 112 and holds the canula 103. Yes.
A large-diameter portion 111a exposed to the outside when the needle assembly 101 is used and a small-diameter portion 111b provided at the tip of the large-diameter portion 111a are formed on the outer peripheral surface of the main body portion 111. These large-diameter portions On the outer peripheral surfaces of 111a and the small-diameter portion 111b, a flat surface 111c is formed at opposing positions.
Further, projections 111d are formed on the flat surface 111c of the small-diameter portion 111b toward the outside, and an inclined surface is formed in front of the projection 111d.
Furthermore, a threaded portion that is screwed into the cartridge is formed on the inner peripheral surface of the main body 111 behind the bottom portion 112, and the guide means G is configured in front of the bottom portion 112 so as to face the opposing portion. A wedge-shaped groove 111e is formed.
 上記筒状部106には、先端に形成されて内周側に膨出するフランジ131と、外周面の対向する位置に形成された2つの平坦面132と、該平坦面132に形成された係合穴132aと、上記平坦面111cに対して約70°回転した位置に形成された2つの貫通孔133とが設けられている。
 筒状部106の内周面には、上記ハブ104の小径部111bが嵌合する薄肉部(図示せず)が形成されるとともに、該薄肉部の前方における上記カヌラ103を挟んで対向する位置には、上記ガイド手段Gを構成する溝106aが前後方向に向けて形成されている。
 上記平坦面132は、上記ハブ104の平坦面111cと直線上に整列するように形成され、ハブ104を筒状部106に挿入することにより、上記ハブ104の突起111dが上記係合穴132aに嵌合し、ハブ104と筒状部106とが連結されるようになっている。
The cylindrical portion 106 includes a flange 131 formed at the tip and bulging toward the inner peripheral side, two flat surfaces 132 formed at opposite positions on the outer peripheral surface, and an engagement formed on the flat surface 132. A joint hole 132a and two through holes 133 formed at a position rotated about 70 ° with respect to the flat surface 111c are provided.
A thin portion (not shown) into which the small-diameter portion 111b of the hub 104 is fitted is formed on the inner peripheral surface of the tubular portion 106, and a position facing the canula 103 in front of the thin portion. The groove 106a constituting the guide means G is formed in the front-rear direction.
The flat surface 132 is formed so as to be aligned with the flat surface 111c of the hub 104 in a straight line. By inserting the hub 104 into the cylindrical portion 106, the protrusion 111d of the hub 104 is inserted into the engagement hole 132a. The hub 104 and the cylindrical portion 106 are connected to each other.
 そして、図9に示すように、ハブ104と筒状部106とを連結すると、該ハブ104と筒状部106とからなるハブ体の内周面にガイド手段Gが形成されるようになっている。
 具体的には、上記筒状部106に形成された貫通孔133および溝106aの後方に、上記ハブ104の内周面に形成された溝111eが位置するようになっている。
 上記溝106aは上記貫通孔133に対して所定角度回転した位置に形成されており、また溝106aの先端部の位置は、上記貫通孔133よりも前方に位置するようになっている。
 そして、上記溝106aが使用前状態において上記係合突起124を保持する使用前保持部Aを構成し、上記貫通孔133が使用後状態において上記係合突起124と係合する使用後保持部Bを構成し、これら使用前保持部Aと使用後保持部Bとの間には回転防止突起134が形成されている。
 上記ハブ104の溝111eは上記筒状部106の溝106aおよび貫通孔133の幅に合わせて形成され、上記使用前保持部A側から使用後保持部B側に向けて後方に傾斜する傾斜面114aが形成されるとともに、上記回転防止突起134の後方には戻り防止突起135が形成されている。
As shown in FIG. 9, when the hub 104 and the cylindrical portion 106 are connected, the guide means G is formed on the inner peripheral surface of the hub body composed of the hub 104 and the cylindrical portion 106. Yes.
Specifically, a groove 111e formed on the inner peripheral surface of the hub 104 is positioned behind the through hole 133 and the groove 106a formed in the cylindrical portion 106.
The groove 106 a is formed at a position rotated by a predetermined angle with respect to the through hole 133, and the position of the tip of the groove 106 a is positioned in front of the through hole 133.
The groove 106a constitutes a pre-use holding portion A that holds the engaging protrusion 124 in a pre-use state, and the post-use holding portion B that the through-hole 133 engages with the engaging protrusion 124 in a post-use state. An anti-rotation protrusion 134 is formed between the holding part A before use and the holding part B after use.
The groove 111e of the hub 104 is formed in accordance with the widths of the groove 106a and the through hole 133 of the cylindrical portion 106, and is an inclined surface that is inclined backward from the pre-use holding portion A side toward the post-use holding portion B side. 114 a is formed, and a back prevention protrusion 135 is formed behind the rotation prevention protrusion 134.
 上記構成を有する針組立体101の使用方法を説明すると、図9(a)は針組立体101の使用前状態を示し、保護カバー107は係合突起124が上記使用前保持部Aに位置するとともに、保護カバー107によりカヌラ103が囲繞された状態となっている。
 このとき、上記係合突起124は上記回転防止突起134によって使用後保持部B側への回転が阻止されている。
 次に、図9(a)の状態から使用者が筒状部106を把持しながら注射器を患者の皮膚に対して略垂直方向に押し当てると、保護カバー107が後退して図9(b)に示すようにカヌラ103の先端が若干露出し、上記係合突起124が傾斜面114aに前方から当接して斜め後方に移動する。
 このとき、上記保護カバー107における係合部122におけるカバー部121との境界に傾斜面122aを形成することで、保護カバー107が回転しながら後退する際に、上記筒状部106のフランジ131との間で発生する摩擦が低減され、スムーズに保護カバー107を後退させることが可能となっている。
The method of using the needle assembly 101 having the above configuration will be described. FIG. 9A shows a state before the needle assembly 101 is used, and the protective projection 107 of the protective cover 107 has the engaging projection 124 positioned at the holding portion A before use. At the same time, the cannula 103 is surrounded by the protective cover 107.
At this time, the engagement protrusion 124 is prevented from rotating toward the post-use holding portion B by the rotation prevention protrusion 134.
Next, when the user presses the syringe against the patient's skin in a substantially vertical direction while grasping the cylindrical portion 106 from the state of FIG. 9A, the protective cover 107 moves backward and FIG. 9B. As shown, the tip of the cannula 103 is slightly exposed, and the engagement protrusion 124 contacts the inclined surface 114a from the front and moves obliquely backward.
At this time, by forming the inclined surface 122a at the boundary of the engaging portion 122 of the protective cover 107 with the cover portion 121, when the protective cover 107 moves backward while rotating, the flange 131 of the tubular portion 106 and The friction generated between the protective cover 107 and the protective cover 107 can be smoothly retracted.
 その後、さらに保護ユニット105が回転しながら後退すると図9(c)に示す使用状態となり、この際上記係合突起124が戻り防止突起135を乗越えるようになっている。
 そして、使用者がカートリッジに所要の操作を行ってインシュリンの投与を行い、その後、注射器を後退させると、ばね部108の付勢力によって保護カバー107が前進位置に位置し、図9(d)の使用後状態となる。
 このとき、係合突起124は回転せずに前進して、使用後保持部Bとしての貫通孔133の位置まで前進し、上記変形部123の弾性力によって外部に突出して該貫通孔133に係合することで、その後の保護カバー107の後退を阻止するようになっている。
 ここで、上記貫通孔133の位置は上記使用前保持部Aとしての溝106aの位置よりも後方に位置していることから、使用前状態に比べて、使用後状態における保護カバー107の先端の位置は後方に位置するようになっている。
Thereafter, when the protection unit 105 further moves backward while rotating, the use state shown in FIG. 9C is entered, and at this time, the engagement protrusion 124 gets over the return prevention protrusion 135.
Then, when the user performs the required operation on the cartridge to administer insulin and then the syringe is retracted, the protective cover 107 is positioned at the advanced position by the urging force of the spring portion 108, and FIG. After use.
At this time, the engaging protrusion 124 moves forward without rotating, moves forward to the position of the through hole 133 as the post-use holding portion B, protrudes to the outside by the elastic force of the deforming portion 123, and engages with the through hole 133. As a result, the protective cover 107 is prevented from moving backward thereafter.
Here, since the position of the through hole 133 is located behind the position of the groove 106a as the pre-use holding portion A, the tip of the protective cover 107 in the post-use state is compared with the pre-use state. The position is located rearward.
 このように、上記第2実施例における針組立体101であっても、上記第1実施例における針組立体1と全く同じ操作によってインシュリンの投与を行うことが可能となっている。
 そして、上記第1実施例における針組立体1と同様、一旦使用後状態になると、保護カバー107の係合突起124が貫通孔133によって移動不可に固定されるので、カヌラ3の再露出が阻止され、針組立体101の再利用や誤穿刺事故を防止することができる。
 また、上記保護ユニット105を一体成形しているため、従来の金属製のばねを用いる針組立体に比べて部品点数を抑えることができ、また組み立ても容易となる。
 さらに、上記保護カバー107とばね部108とを直列に配置することで、保護カバー107とばね部108とを連結した形状は複雑とならず、一体成形を容易に行うことができ、針組立体101を小型化することができる。
 そして、使用前状態から使用状態にする際には、保護カバー107の係合突起124がガイド手段Gの傾斜面114aによって回転しながら後退し、かつ使用状態から使用後状態にする際には、保護カバー107はばね部108の付勢力によってまっすぐ前方に移動するので、使用後に係合突起124が使用前保持部Aへと戻ってしまうのを可及的に阻止することができる。
 さらに、上記使用前保持部Aと使用後保持部Bとの間に戻り防止突起135を設けているので、係合突起124の使用前保持部Aへの戻りを阻止することができ、より確実に係合突起124を使用後保持部Bまで導くことができる。
As described above, even in the needle assembly 101 in the second embodiment, insulin can be administered by exactly the same operation as the needle assembly 1 in the first embodiment.
As in the case of the needle assembly 1 in the first embodiment, the engagement protrusion 124 of the protective cover 107 is fixed so as not to be moved by the through-hole 133 once it is in the used state, thereby preventing re-exposure of the cannula 3. Thus, reuse of the needle assembly 101 and accidental puncture can be prevented.
Further, since the protection unit 105 is integrally formed, the number of parts can be reduced as compared with a conventional needle assembly using a metal spring, and assembly is facilitated.
Further, by arranging the protective cover 107 and the spring portion 108 in series, the shape of connecting the protective cover 107 and the spring portion 108 is not complicated, and can be easily formed integrally, and the needle assembly 101 can be reduced in size.
Then, when changing from the pre-use state to the use state, the engaging projection 124 of the protective cover 107 is rotated back by the inclined surface 114a of the guide means G, and when changing from the use state to the post-use state, Since the protective cover 107 moves straight forward by the urging force of the spring portion 108, it is possible to prevent the engagement protrusion 124 from returning to the pre-use holding portion A as much as possible after use.
Furthermore, since the return prevention protrusion 135 is provided between the holding part A before use and the holding part B after use, it is possible to prevent the engagement protrusion 124 from returning to the holding part A before use, and more reliably. The engaging protrusion 124 can be guided to the holding portion B after use.
 次に、上記第1、第2実施例では、保護カバー7に係合突起24を設け、ハブ体にガイド手段Gを設けた構成となっているが、逆に保護カバー7にガイド手段Gを設け、ハブ体に係合突起を設けてもよい。
 具体的に説明すると、図10は第3実施例にかかる針組立体201の使用後状態を示し、以下の説明において、上記第1実施例の針組立体1と共通する部材についてはその符号に200を加算して説明する。
 第1実施例と同様、針組立体201は、カヌラ203を保持するハブ204と、ハブ204に対して進退動して上記カヌラ203の先端を囲繞する保護ユニット205と、ハブ204の前方に連結されて上記保護ユニット205の外周を囲繞する筒状部206とから構成され、上記ハブ204と筒状部206とは連結することでハブ体を構成するようになっている。
 上記保護ユニット205は、上記第1実施例と同様、保護カバー207とばね部208とが直列に一体成形されており、また保護カバー207における係合部207aの側面にはガイド手段Gが形成されている。
 上記ハブ体を構成する筒状部206には、内周面に向けて突出する係合突起206aが設けられ、この係合突起206aは変形部206bによって外周側に移動可能となっており、図8では該係合突起206aは保護カバー207の係合部207aに形成された使用後保持部Bとしての貫通孔207bに係合して、保護カバー207の後退を阻止するようになっている。
 そして、上記ガイド手段Gは、上記使用後保持部Bに隣接した位置に図示しない使用前保持部Aを備え、これら使用後保持部Bと使用前保持部Aの前方には、使用前保持部A側から使用後保持部B側にかけて前方に傾斜する傾斜面207cが形成されている。
 また、使用後保持部Bと使用前保持部Aの間には、図示しない回転防止突起および戻り防止突起207dが形成されている。
Next, in the first and second embodiments, the protective cover 7 is provided with the engaging protrusion 24 and the hub body is provided with the guide means G. Conversely, the guide means G is provided on the protective cover 7. The engaging protrusion may be provided on the hub body.
More specifically, FIG. 10 shows a state after use of the needle assembly 201 according to the third embodiment. In the following description, members common to the needle assembly 1 of the first embodiment are designated by the reference numerals. An explanation will be given by adding 200.
As in the first embodiment, the needle assembly 201 is connected to the hub 204 that holds the cannula 203, the protection unit 205 that moves forward and backward with respect to the hub 204 to surround the tip of the cannula 203, and the front of the hub 204. The cylindrical portion 206 surrounds the outer periphery of the protection unit 205, and the hub 204 and the cylindrical portion 206 are connected to form a hub body.
In the protective unit 205, as in the first embodiment, the protective cover 207 and the spring portion 208 are integrally formed in series, and a guide means G is formed on the side surface of the engaging portion 207a of the protective cover 207. ing.
The cylindrical portion 206 constituting the hub body is provided with an engaging protrusion 206a that protrudes toward the inner peripheral surface, and the engaging protrusion 206a can be moved to the outer peripheral side by the deforming portion 206b. In FIG. 8, the engaging protrusion 206 a is engaged with a through hole 207 b as a post-use holding portion B formed in the engaging portion 207 a of the protective cover 207 so as to prevent the protective cover 207 from retreating.
The guide means G includes a pre-use holding part A (not shown) adjacent to the post-use holding part B, and the pre-use holding part in front of the post-use holding part B and the pre-use holding part A. An inclined surface 207c that is inclined forward from the A side to the post-use holding part B side is formed.
Further, between the post-use holding part B and the pre-use holding part A, a rotation prevention protrusion and a return prevention protrusion 207d (not shown) are formed.
 このような構成により、使用前状態から保護カバー207を後退させると、筒状部206の係合突起206aに対してガイド手段Gが相対的に後方に移動し、傾斜面207cが該係合突起206aに当接する。
 その後、傾斜面207cが係合突起206aに当接することで保護カバー207は回転しながら後退し、カヌラ203が突出した使用状態となるとともに、その際係合突起206aは上記戻り防止突起207dを乗越える。
 そして、使用状態から保護カバー207が前進すると、係合突起206aに対してガイド手段Gが前方に移動し、使用後保持部Bとしての貫通孔207bに係合突起206aが係合するので、保護カバー207は使用後状態となる。
With such a configuration, when the protective cover 207 is retracted from the pre-use state, the guide means G moves rearward relative to the engagement protrusion 206a of the cylindrical portion 206, and the inclined surface 207c becomes the engagement protrusion 207c. Abuts on 206a.
Thereafter, when the inclined surface 207c comes into contact with the engaging protrusion 206a, the protective cover 207 is rotated and retracted, and the cannula 203 protrudes. At this time, the engaging protrusion 206a gets on the return preventing protrusion 207d. Over.
When the protective cover 207 moves forward from the use state, the guide means G moves forward with respect to the engaging protrusion 206a, and the engaging protrusion 206a engages with the through hole 207b as the holding portion B after use. The cover 207 is in a state after use.
 このように、この第3実施例における針組立体201においても、第1実施例の針組立体1と同様、一旦使用後状態になると、筒状部206の係合突起206aが貫通孔207bによって移動不可に固定されるので、カヌラ203の再露出が阻止され、針組立体201の再利用や誤穿刺事故を防止することができる。
 また、上記保護ユニット205を一体成形し、かつ保護カバー207とばね部208とを直列に配置しているので、従来の針組立体に比べて部品点数を抑えるとともに、一体成形を容易に行うことができ、針組立体を小型化することができる。
 そして、使用前状態から使用状態にする際には、保護カバー207が筒状部206の係合突起206aと傾斜面207cとが係合することで回転しながら後退し、かつ使用状態から使用後状態にする際には、保護カバー207はばね部208の付勢力によってまっすぐ前方に移動するので、使用後に係合突起206aが使用前保持部Aに戻ってしまうのを可及的に阻止することができる。
 さらに、上記使用前保持部Aと貫通孔207bとの間に戻り防止突起207dを設けているので、係合突起206aの使用前保持部Aへの戻りを阻止することができ、より確実に係合突起206aを貫通孔207bまで導くことができる。
As described above, also in the needle assembly 201 in the third embodiment, like the needle assembly 1 in the first embodiment, the engagement protrusion 206a of the cylindrical portion 206 is formed by the through-hole 207b once in the post-use state. Since it is fixed so that it cannot move, re-exposure of the cannula 203 is prevented, and reuse of the needle assembly 201 and an accidental puncture can be prevented.
In addition, since the protection unit 205 is integrally molded and the protective cover 207 and the spring portion 208 are arranged in series, the number of parts can be reduced and the integral molding can be easily performed as compared with the conventional needle assembly. And the size of the needle assembly can be reduced.
Then, when changing from the pre-use state to the use state, the protective cover 207 retreats while rotating because the engaging protrusion 206a and the inclined surface 207c of the cylindrical portion 206 are engaged, and after use from the use state. In the state, the protective cover 207 moves straight forward due to the urging force of the spring portion 208, so that the engagement protrusion 206a is prevented from returning to the pre-use holding portion A after use as much as possible. Can do.
Further, since the return prevention protrusion 207d is provided between the holding part A before use and the through hole 207b, the return of the engaging protrusion 206a to the holding part A before use can be prevented, and the engagement is more reliably performed. The mating protrusion 206a can be guided to the through hole 207b.
 1 針組立体           3 カヌラ
 4 ハブ             5 保護ユニット
 6 筒状部            7 保護カバー
 8 ばね部            14a 傾斜面
 24 係合突起          33 貫通孔
 35 戻り防止突起        A 使用前保持部
 B 使用後保持部         G ガイド手段
DESCRIPTION OF SYMBOLS 1 Needle assembly 3 Kanula 4 Hub 5 Protection unit 6 Cylindrical part 7 Protective cover 8 Spring part 14a Inclined surface 24 Engagement protrusion 33 Through-hole 35 Return prevention protrusion A Pre-use holding part B After-use holding part G Guide means

Claims (8)

  1.  カヌラを保持するハブと、ハブに対して進退動して上記カヌラの先端を囲繞する前進位置および上記カヌラの先端を露出させる後退位置に位置する保護カバーと、上記ハブと保護カバーとの間に弾装されて保護カバーを前方に付勢する付勢手段と、上記保護カバーを上記前進位置に保持するストッパ手段とを備えた針組立体において、
     上記ハブに上記保護カバーの外周を囲繞する筒状部を設け、
     かつ、上記付勢手段としてのばね部を上記保護カバーに直列に整列するように設け、これら保護カバーとばね部とを弾性を有する素材で一体的に成形したことを特徴とする針組立体。
    A hub that holds the cannula, a protective cover that is moved forward and backward with respect to the hub to surround the tip of the cannula and a retracted position that exposes the tip of the cannula, and between the hub and the protective cover In a needle assembly comprising an urging means for urging the protective cover forwardly mounted and a stopper means for holding the protective cover in the advanced position,
    A cylindrical portion surrounding the outer periphery of the protective cover is provided on the hub,
    The needle assembly is characterized in that a spring portion as the urging means is provided so as to be aligned in series with the protective cover, and the protective cover and the spring portion are integrally formed of an elastic material.
  2.  カヌラを保持するハブと、ハブに対して進退動して上記カヌラの先端を囲繞する前進位置および上記カヌラの先端を露出させる後退位置に位置する保護カバーと、上記ハブと保護カバーとの間に弾装されて保護カバーを前方に付勢する付勢手段と、上記保護カバーを上記前進位置に保持するストッパ手段とを備え、
     上記保護カバーが、上記前進位置に位置して上記カヌラの先端が囲繞される使用前状態と、保護カバーが上記後退位置に位置して上記カヌラの先端が露出する使用状態と、再び上記前進位置に位置してカヌラの先端が囲繞されるとともに再び後退位置へと移動しないように固定した使用後状態とに移動する針組立体において、
     上記ハブに上記保護カバーの外周を囲繞する筒状部を設けるとともに、これらハブと筒状部とからなるハブ体または保護カバーのいずれか一方に係合突起を、他方に該係合突起の移動を規制するガイド手段をそれぞれ設け、
     上記ガイド手段は、上記係合突起を使用前状態の位置で保持する使用前保持部と、係合突起を使用後状態の位置に固定する使用後保持部と、保護カバーを後退させると係合突起に係合して、保護カバーを上記使用前保持部側位置から使用後保持部側位置に向けて回転させながら後退させる傾斜面とを備え、
     使用前状態から付勢手段の付勢力に抗して保護カバーを後退させると、上記係合突起と傾斜面とが当接して、保護カバーが回転しながら後退して上記使用状態となり、該使用状態から保護カバーを前進させると、係合突起が上記使用後保持部に固定されて使用後状態となることを特徴とする針組立体。
    A hub that holds the cannula, a protective cover that is moved forward and backward with respect to the hub to surround the tip of the cannula and a retracted position that exposes the tip of the cannula, and between the hub and the protective cover An urging means for urging the protective cover forwardly mounted, and stopper means for holding the protective cover in the advanced position;
    The pre-use state in which the protective cover is located at the forward position and the tip of the cannula is surrounded; the use state in which the protective cover is located at the retracted position and the tip of the cannula is exposed; and the forward position again In the needle assembly which is moved to the post-use state where the tip of the cannula is surrounded and fixed so as not to move to the retracted position again,
    The hub is provided with a cylindrical portion that surrounds the outer periphery of the protective cover, and the engaging projection is moved to one of the hub body or the protective cover composed of the hub and the cylindrical portion, and the engaging projection is moved to the other. Each is provided with a guide means to regulate,
    The guide means engages when the pre-use holding portion that holds the engaging protrusion at the pre-use position, the post-use holding portion that fixes the engaging protrusion at the post-use state, and the protective cover is retracted. An inclined surface that engages with the protrusion and retracts the protective cover while rotating from the pre-use holding unit side position toward the post-use holding unit side position,
    When the protective cover is retracted against the urging force of the urging means from the pre-use state, the engaging projection and the inclined surface come into contact with each other, and the protective cover moves backward while rotating to enter the use state. When the protective cover is moved forward from the state, the engagement protrusion is fixed to the post-use holding part to be in the post-use state.
  3.  上記係合突起は保護カバーに設けられるとともに、上記ガイド手段は上記ハブ体に形成され、
     上記傾斜面は上記使用前保持部および使用後保持部の後方に位置するとともに使用前保持部側から使用後保持部側にかけて後方に傾斜し、
     使用前状態から保護カバーを後退させると、係合突起が使用前保持部から後方に移動して上記傾斜面に当接するとともに、係合突起が上記傾斜面に沿って回転しながら斜め後方に移動して上記使用状態となり、
     該使用状態から保護カバーを前進させると、係合突起が前方に移動して上記使用後保持部に固定され、使用後状態となることを特徴とする請求項2に記載の針組立体。
    The engaging protrusion is provided on the protective cover, and the guide means is formed on the hub body,
    The inclined surface is located behind the holding part before use and the holding part after use and is inclined backward from the holding part side before use to the holding part side after use,
    When the protective cover is retracted from the pre-use state, the engaging protrusion moves rearward from the pre-use holding portion and contacts the inclined surface, and the engaging protrusion moves obliquely backward while rotating along the inclined surface. And the above usage state
    3. The needle assembly according to claim 2, wherein when the protective cover is moved forward from the use state, the engagement protrusion moves forward and is fixed to the post-use holding portion to be in the post-use state.
  4.  上記使用後保持部の位置に貫通孔を形成し、
     該貫通孔に上記保護カバーの係合突起が挿入されると、係合突起と貫通孔とが相互に係合して、係合突起が該貫通孔によって移動不能に固定されることを特徴とする請求項3に記載の針組立体。
    A through hole is formed at the position of the holding part after use,
    When the engaging protrusion of the protective cover is inserted into the through hole, the engaging protrusion and the through hole are engaged with each other, and the engaging protrusion is fixed to be immovable by the through hole. The needle assembly according to claim 3.
  5.  上記係合突起が上記傾斜面に沿って移動する経路上に、使用前保持部側から使用後保持部側へと徐々に突出するように傾斜する戻り防止突起を設け、
     保護カバーを使用前状態から使用状態に移動させて、上記係合突起が戻り防止突起を乗越えると、係合突起は該戻り防止突起によって使用前保持部側への回転が規制されることを特徴とする請求項3または請求項4のいずれかに記載の針組立体。
    On the path along which the engaging protrusion moves along the inclined surface, a return preventing protrusion that is inclined so as to gradually protrude from the holding part before use to the holding part after use is provided.
    When the protective cover is moved from the pre-use state to the use state and the engagement protrusion gets over the return prevention protrusion, the engagement protrusion is restricted from rotating toward the holding part before use by the return prevention protrusion. The needle assembly according to claim 3 or 4, characterized in that it is characterized in that:
  6.  上記筒状部に上記使用前保持部および使用後保持部を形成し、上記ハブに上記傾斜面を形成したガイド部を設けて、ハブおよび筒状部を嵌合させることで、上記ガイド手段が得られることを特徴とする請求項3ないし請求項5のいずれかに記載の針組立体。 The guide means is formed by forming the pre-use holding portion and the post-use holding portion in the cylindrical portion, providing a guide portion in which the inclined surface is formed on the hub, and fitting the hub and the cylindrical portion together. The needle assembly according to any one of claims 3 to 5, wherein the needle assembly is obtained.
  7.  上記ストッパ手段は、保護カバーの前方に向けて形成された係合面と、筒状部の後方に向けて形成された被係合面とから構成され、
     上記係合面が被係合面の後方から当接することにより、保護カバーが前進位置に保持されることを特徴とする請求項1ないし請求項6のいずれかに記載の針組立体。
    The stopper means is composed of an engaging surface formed toward the front of the protective cover and an engaged surface formed toward the rear of the cylindrical portion,
    The needle assembly according to any one of claims 1 to 6, wherein the protective cover is held in an advanced position by the contact of the engaging surface from behind the engaged surface.
  8.  インシュリンを収容したカートリッジの先端に上記針組立体を装着したことを特徴とする請求項1ないし請求項7のいずれかに記載の針組立体を備えたインシュリン注射器。 The insulin syringe provided with the needle assembly according to any one of claims 1 to 7, wherein the needle assembly is attached to a tip of a cartridge containing insulin.
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EP2298394A1 (en) 2011-03-23
US20110077600A1 (en) 2011-03-31
CA2728148C (en) 2016-10-18
CA2728148A1 (en) 2009-12-23
JPWO2009154131A1 (en) 2011-12-01
EP2298394A4 (en) 2017-11-22
US9061105B2 (en) 2015-06-23
JP5267560B2 (en) 2013-08-21

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